+1-757-224-0177     
EN
24/7 Live Chat Call Us

FDA Orders First Ever Mandatory Recall Under FSMA

On April 3rd, 2018, the U.S. Food and Drug Administration (FDA) ordered a mandatory recall of all food products that contain powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC. The Agency issued the order after several samples of kratom products manufactured by the Las Vegas based company tested positive for salmonella, a potentially dangerous pathogen known to cause diarrhea, fever, and abdominal cramps. This is the first time FDA has ever issued a mandatory recall order. FDA Commissioner Scott Gottlieb, M.D. stated that the action was “based on the imminent health risk posed by the contamination of this product… and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions (FDA.gov).”

Section 206 of the Food Safety Modernization Act of 2011 (FSMA) grants FDA the authority to order responsible parties to recall certain food articles if the Agency determines that there is a reasonable probability that a particular food product is adulterated or misbranded and that the use of or exposure to that food product will cause serious adverse health consequences or death to humans or animals. Despite this authority, FDA still relies on responsible parties to voluntarily recall products that are in violation of regulations. The Agency issued this mandatory order only after Triangle Pharmanaturals LLC failed to comply with earlier requests that the firm cease distribution and recall the product voluntarily.

Both voluntary and mandatory recalls can permanently damage a brand’s reputation. Companies that wish to reduce the risk of facing a recall may take various measures to help ensure that their products meet required regulatory standards and do not pose a threat to human or animal health. Registrar Corp offers a number of services specifically designed to make complying with FDA regulations easier for businesses. For example, Registrar Corp can dispatch a Food Safety Specialist to your facility to help you prepare for an FDA inspection by identifying potential food safety problems in the structure, processes, procedures and documentation used in your daily production. Furthermore, Registrar Corp can develop new food safety plans and programs for your facility or review your current systems and documentation. Businesses may also use Registrar Corp’s FDA Compliance Monitor to track suppliers, importers, and distributors for FDA warning letters, import alerts, and more so that they may become aware of and react to any FDA regulatory difficulties faced by current or potential commercial partners in their supply chain. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours-a-day at www.registrarcorp.com/livehelp.

FDA Draft Guidance Explains Small Business Definition For Preventive Controls Rules

The U.S. Food and Drug Administration (FDA) recently published a draft guidance on how to determine whether a business is a “small business” under the Preventive Controls for Human and Animal Food Rules.  The rules define a “small business” as having fewer than 500 “full-time equivalent employees.” Small businesses are subject to different compliance deadlines and, in some cases, different requirements than other businesses sizes. The recent guidance demonstrates that the definition of full-time equivalent employee may exclude many facilities from small business classification.

What is a Full-time Equivalent Employee?

As outlined by 21 CFR Part 117, the number of full-time equivalent employees for a given facility is determined by dividing the total number of hours worked in one year by all of the business’s staff (including those that do not handle food and those employed by affiliates and subsidiaries) by the number of hours one full-time employee would work in one year (i.e. 2,080).

For example, a facility may employ 150 full-time employees at 40 hours per week and 200 part-time employees at 30 hours per week for food manufacturing roles (a total of 624,000 hours in a year).  The facility may be a division of a legal entity that employs 150 full-time employees and an additional 250 part-time employees across multiple subsidiaries for various roles unrelated to food manufacture (an additional 702,000 hours in a year).  Though the facility only has 150 full-time employees, the legal entity it comprises actually has 637 full-time equivalent employees (1,326,000 hours divided by 2,080).

For this reason, some facilities may not realize that they are actually subject to requirements for large businesses under the Preventive Controls Rules.

How Does Business Size Affect Preventive Controls Requirements?

The rules provide small businesses a longer timeframe than their larger counterparts to develop written Food Safety Plans required by the Preventive Controls Rules; however, the compliance deadlines for most food facilities have passed, and small animal food businesses only have until September 17, 2018 to comply with preventive control requirements.

Certain farms that engage in activities requiring FDA registration (e.g. processing) may be exempt from requirements under the rule if they are considered a small business, but large farms that engage in these activities are required to have Food Safety Plans in place.

Additionally, “very small businesses” (defined by the rules as averaging less than $1,000,000 per year in sold and unsold products during the preceding three-year calendar period) are required to submit a “Qualified Facility Attestation” to FDA.  These facilities receive modified preventive controls requirements, including exemption from developing Food Safety Plans.  Facilities who submit an attestation must ensure that the average value per year of their sold and unsold products does not exceed $1,000,000, or they may be providing false statements to FDA.  Submitting false statements to a U.S. federal agency is a criminal offense.

It is wise for covered facilities to develop Food Safety Plans immediately.  FDA may look for a Food Safety Plan as part of a routine facility inspection, and U.S. importers may request their suppliers’ Food Safety Plan as part of a required supplier approval process.

Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) who can develop a Food Safety Plan for your facility or review your current plan for compliance.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours-a-day at www.registrarcorp.com/livehelp.

2017 in Review – U.S. FDA Food and Beverage Regulations

2017 brought a host of changes for food manufacturers and importers.  The U.S. Food and Drug Administration (FDA) had a year of announcements, proposals, and deadlines for the food and beverage industry.  Perhaps most notable were the passing of two compliance dates for rules under the Food Safety Modernization Act (FSMA) and a proposed extension of the compliance date for FDA’s new food label rules.  Take a look below at some of the regulatory highlights that occurred this year.

FDA Removed 28% of Food Facility Registrations from its Database

Between January 2016 and February 2017, FDA removed 57,720 food facility registrations from its database.  The drop in registrations was likely caused by facilities not properly registering before the December 2016 deadline and U.S. Agents of foreign facilities not confirming acceptance of this role with FDA.

Australia Received Systems Recognition with U.S. FDA

In April, FDA recognized the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System to the United States.  Australia follows New Zealand and Canada as the third country to receive this recognition.  U.S. Importers may receive exemptions from certain requirements in their Foreign Supplier Verification Programs (FSVPs) if their suppliers are in “good compliance standing” with a recognized country’s regulating authority.

As of this writing, the three recognized countries have not published lists of firms in good compliance standing.  As a result, suppliers in these countries are unable to benefit from the competitive advantage that more relaxed FSVP requirements for importers would grant them.

The FSVP Compliance Deadline for Most US Importers Passed

The first compliance deadline for the FSVP Rule passed on May 30, 2017.  Among other requirements, covered importers must monitor and document their foreign suppliers’ FDA compliance, evaluate the level of health risk their suppliers pose, and conduct appropriate verification activities relative to this evaluation.  In August, FDA began inspecting covered importers for their compliance with FSVP requirements.  The next FSVP compliance date is March 19, 2018.

Compliance Dates Passed under the Preventive Controls Rules

Larger animal food and smaller human food businesses were required to develop and implement written Food Safety Plans by September 18, 2017.  These plans, overseen by a “Preventive Controls Qualified Individual” (PCQI), involve an analysis of reasonably known or foreseeable hazards and preventive controls for these hazards.  Smaller animal food businesses were required to begin implementing Current Good Manufacturing Practices (CGMPs) by this deadline.

FDA Proposed Extension of Label Rule Compliance Dates

In September, FDA proposed an extension of the compliance deadline for new food labeling rules to January 1, 2020 for food manufacturers grossing $10 million or more in annual sales.  Smaller businesses would be provided an additional year.  Despite the proposed extension, we urge facilities to take steps toward compliance now. FDA issued this proposal after manufacturers expressed concerns over being able to comply with the initial deadline of July 2018.

FDA Proposed to Revoke Authorized Health Claim for Soy Protein

FDA issued a proposal to revoke an authorized health claim linking soy protein to a decreased risk of coronary heart disease.  Since the claim’s authorization in 1999, the “totality of scientific evidence” surrounding the relationship has yielded inconsistent findings.  This caused FDA to determine that it did not present the significant scientific agreement required of an authorized health claim.

FDA Issued Draft Guidance for Refusal of Inspection

In December, FDA issued a guidance outlining the Agency’s interpretation of the term “refusal of inspection.”  FDA states that, among other actions, failure to respond to an inspection request within 24 hours may constitute a refusal.  Food facilities that refuse inspection are placed under Import Alert, and their products are refused at the port of U.S. entry.

Registrar Corp remains committed to keeping the food industry informed on pressing regulatory matters and will continue to issue critical information in 2018.  The numerous requirements that came into effect this year and those approaching in 2018 may be overwhelming.  Registrar Corp can offer assistance.  Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Releases FY 2017 Inspectional Observations; Registrar Corp Reports on Common Food Safety Violations

5 Inspection Violations Commonly Found by FDAThe U.S. Food and Drug Administration (FDA) recently released its inspectional observation data for fiscal year (FY) 2017.  The data presents an overview of violations cited by FDA during routine food facility inspections from October 2016 through September 2017.  FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations:

  • Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.
  • Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs).  Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.
  • Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.
  • HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan’s hazard control, or maintaining records as required by 21 CFR Part 123
  • Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food.  Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.

The violations listed above are nearly identical to the most common violations cited in FY 2016 and FY 2015.  Food facilities should use this pattern to anticipate what areas in their daily operations may require further review before a FDA inspection.

It is worth mentioning that the 2017 list is the first to include violations related to FDA’s Preventive Controls Rules and Foreign Supplier Verification Program (FSVP) Rule, both of which had compliance deadlines in 2017.  Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times.  With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.

Inspection violations can result in Warning Letters, placement on Import Alert, suspension of facility registration, and other enforcement actions.  With proper preparation and guidance, these food safety issues can be corrected before FDA visits a facility.  Registrar Corp’s Food Safety Specialists can conduct a mock FDA inspection of your facility to identify potential food safety violations.  Our expert, onsite assistance can guide your facility with knowledge and tools to have a successful FDA inspection.  For more information, visit our site or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

This article was originally published as a press release.

FDA Requires Responses to Inspection Requests within 24 Hours, According to New Inspection Refusal Guidance

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance that outlines their interpretation of the term “refusal of inspection.”  According to the guidance, FDA requires food facilities receiving notice of FDA inspection to confirm acceptance of the inspection within 24 hours. Failure to confirm within 24 hours may be deemed refusal of inspection, resulting in refusal of that facility’s future food shipments to the US.  Further, any attempts to limit or condition the inspection in any way likewise may be deemed a refusal of inspection, with the same harsh consequences.

What are the Consequences of Being Deemed a Refusal?

Facilities that refuse inspection are placed under Import Alert 99-32, and their food articles face refusal of admission at the port of U.S. entry.  In addition, their FDA registration may be suspended.

How Can I Prevent Being Deemed a Refusal?

The recent guidance amplifies the importance of understanding FDA’s expectations for the inspection process and having a reliable U.S. Agent as a guide.  Before the inspection begins, the Agency may interpret actions such as not agreeing to an inspection start date or rescheduling an inspection without reasonable explanation as attempts to circumvent the inspection.  Upon receiving a notice of inspection, a facility should work with their U.S. Agent to respond to FDA promptly and cooperatively.

During the inspection, a facility should maintain this cooperation with the FDA inspector.  Any attempts to interfere with or delay the inspection, such as limiting the inspector’s observations to certain areas of the plant or omitting requested documents, may constitute refusal.  Facilities should ensure that they accommodate the inspector’s requests and refrain from any actions that might limit a full observation of daily operations.

Our Facility Is Under Import Alert for Inspection Refusal.  What Can We Do?

To seek removal from the Import Alert 99-32 Red List, a facility must petition for inspection by FDA.  The guidance states that for some facilities, scheduling an inspection after an initial refusal may take at least one year.  Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.

Proper guidance from a third party experienced in FDA regulations can prove invaluable to a facility facing inspection.  Registrar Corp’s trained Regulatory Specialists are knowledgeable in FDA inspections and can conduct a Mock FDA Inspection of your facility.  Our experts can help identify potential food safety issues to fix before an inspection and educate facility staff on FDA expectations. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Registrar Corp can act as your U.S. Agent to help you promptly schedule inspection with FDA, as well as provide your facility a host of additional benefits, including biennial registration, detention assistance, and compliance monitoring.

 

Why Food Facilities Should Get Off FDA Import Alert Before March 2018

The U.S. Food and Drug Administration (FDA) requires most U.S. importers of food and beverages to develop and implement Foreign Supplier Verification Programs (FSVPs). Covered importers must document their foreign suppliers’ FDA compliance, including whether or not each supplier is subject to a FDA Import Alert.

Under FSVP, importers must only import from suppliers whom they have evaluated and approved. FDA requires verification activities outlined in a FSVP to be decided by the level of supplier risk determined from this evaluation.  An Import Alert increases the probability that the importer must conduct more comprehensive verification activities to ensure the safety of a supplier’s products, such as onsite audits or sampling.  In some cases, the importer may be unable to approve a supplier because they are under Import Alert.  For these reasons, suppliers not on alert receive a competitive advantage in the market.

The next FSVP deadline is March 19, 2018, which applies to U.S. importers whose suppliers have fewer than 500 full-time equivalent employees. Before the deadline, food facilities outside of the United States should ensure that they are not subject to an Import Alert that may cause their U.S. Importers to not approve them.

What is an Import Alert?

Products on Import Alert face detention without physical examination (DWPE) at the port of entry. FDA issues Import Alerts when patterns of non-compliance from a specific business or country give the Agency reasonable belief that future shipments may violate regulations.

For example, FDA sampled 16 shipments of dried peppers from ten different shippers in Mexico in 1988.  FDA found excessive mold in 14 of those samples.  This led to the publication of Import Alert #24-11, which subjects all shipments of dried peppers from Mexico to DWPE unless the shipper’s product is exempt.  This is just one instance of over 240 active FDA Import Alerts.

How do I know if my products are on Import Alert?

FDA does not directly notify a facility that it is under Import Alert.  Instead, the Agency maintains a public database of Import Alerts with records of which products from which facilities are subject to DWPE. However, determining if products are on Import Alert may require time-consuming searches through numerous alerts for any facilities a given business might have a stake in.  Registrar Corp’s FDA Compliance Monitor is a simple alternative that allows businesses to track all of their facilities at once and receive a detailed report of any alerts their products may be under.

My Products are on Import Alert.  How do I get them removed?

A business may petition FDA for exclusion from an Import Alert by demonstrating evidence of compliance that overcomes the apparent violation detailed in the Alert. A common misconception is that a facility is excluded from Import Alert after five consecutive non-violative shipments are released by FDA.  This is only a small component of a larger process involving other, potentially extensive requirements.

The specific requirements for a petition vary, and are outlined in the guidance issued with an individual Import Alert.  These may include documentation of revised food safety plans, revised labeling or formulations, changes implemented in the manufacturing process, or documentation of compliance with a government agency regulating food in the facility’s home country.

Many businesses can be intimidated by the extensive requirements of an Import Alert petition.  These businesses may remain under Import Alert, facing DWPE and difficulties satisfying the requirements of an importer’s FSVP, even if they are not in violation of the specified regulations at the time.  Despite a solution to the problem, some businesses might have no idea how to begin a petition.

Registrar Corp’s Regulatory Specialists are experienced in developing Import Alert petitions and can help you draft and compile the necessary documentation for Import Alert exclusion.  Additionally, importers and suppliers can try Registrar Corp’s FDA Compliance Monitor free for 60 days to see which of their facilities may be on alert.  For assistance, call us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

 

What’s next for U.S. Importers under FSMA? Registrar Corp reports on recently passed and upcoming compliance deadlines

The small business compliance deadline for the U.S. Food and Drug Administration (FDA) Preventive Controls Rule for Human Food passed on September 18, 2017.  Under the Foreign Supplier Verification Program (FSVP) Rule, many U.S. importers have six months from this deadline (until March 19, 2018) to implement FSVPs for foreign suppliers of human food that qualify as small businesses (defined as having fewer than 500 full-time equivalent employees).

FSVPs consist of documenting several detailed components for each foreign supplier and each category of their imported food products (i.e. chocolate confectionary, bottled oils, etc.)  In order to ensure compliance before the deadline, Registrar Corp urges importers to begin creating their FSVPs now.

What do I need to develop FSVPs?

FDA requires the following, among other things, of importers covered by the March deadline.

Documentation of supplier compliance:

Importers are required to ensure that they import from suppliers whom they have evaluated and approved through various methods that outline the potential health risks their products pose. A covered importer must ensure that a supplier is compliant with preventive controls rules, including the implementation of a food safety plan, and allergen labeling rules.  The importer must also monitor the supplier’s FDA compliance history.

Should an approved supplier be found non-compliant, FDA requires importers to take corrective actions.  These may involve facilitating the development of the supplier’s Food Safety Plan or ceasing business with them until they become compliant.

Hazard analysis of food products:

The FSVP rule requires importers to document a detailed hazard analysis of each category of food products they import from a given supplier.  The analysis should identify any known or reasonably foreseeable hazards that could pose illness or injury, as well as the potential risks involved in the supplier’s handling of the food during manufacturing procedures, storage, and transport.

The data obtained by this hazard analysis should be used to determine appropriate supplier verification activities relative to the level of risk these products pose, such as sampling or onsite audits of a food facility.

Why should I begin building my FSVPs now?

Developing the required documentation can be a lengthy process. A single supplier may need multiple FSVPs.  Importers should make efforts to ensure they comply in time to be prepared for possible inspection.  Registrar Corp saw evidence of FSVP inspections occurring within three months following the May 2017 FSVP compliance date.

Registrar Corp provides a variety of services to assist U.S. importers and their suppliers with requirements under the Food Safety Modernization Act (FSMA).  Registrar Corp’s Food Safety Team consists of Qualified Individuals who are well-versed in the development of FSVPs and Food Safety Plans.  Additionally, Registrar Corp’s FDA Compliance Monitor provides a simple solution to monitoring and approving suppliers as required under FSVP.  Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

This article was originally published as a press release.

Compliance Date Approaching for FSMA Preventive Controls Rules

September 18, 2017 marks the next compliance date under the Preventive Controls for Human and Animal Food Rules of the 2011 Food Safety Modernization Act (FSMA).  The U.S. Food and Drug Administration (FDA) will require larger animal food businesses and smaller human food businesses with fewer than 500 full-time employees to begin complying with preventive controls requirements that include the development and implementation of written Food Safety Plans.  Small animal food businesses with fewer than 500 full-time employees must implement Current Good Manufacturing Practices (CGMP) established by the animal food rule and will be expected to comply with remaining preventive controls requirements next year on September 17, 2018.

Compliance with preventive controls and CGMPs may involve considerable time and effort to achieve.  While FDA has stated that it does not plan to conduct routine inspections on these specific areas immediately, the agency has suggested that it may react in response to a food safety issue or complaint.  In order to ensure your facility is prepared for compliance at all times, Registrar Corp provides important information regarding what will be expected of covered food facilities this September.

What does compliance look like?

For larger animal food and smaller human food businesses:

Food businesses complying with preventive controls will be required to develop and implement written Food Safety Plans that feature an analysis of known or reasonably foreseeable food hazards as well as the measures required to prevent or minimize their threat to public health.  Within this plan, covered food facilities should document appropriate monitoring and verification of their specified preventive controls.  Examples include appropriate controls for Salmonella, appropriate controls for potential mycotoxins and for nutrient deficiencies or toxicities, and evidence that scientifically validates proposed preventive measures.

As part of this plan, FDA requires any covered food facility that identifies hazards needing preventive controls to develop a written recall plan.  The plan should establish detailed procedures that outline how the buyer of the food and the public will be notified of the recall and hazard in question.  It should also outline the steps that will be taken to verify that the recall is being enacted and the method that will be used to properly dispose of the recalled food.

Food Safety Plans can be complicated, and FDA requires a “Preventive Control Qualified Individual,” defined by FDA as an individual with appropriate training or job experience to effectively carry out the requirements under these regulations, to develop them.  Registrar Corp’s Regulatory Specialists possess the requisite qualifications to develop a Food Safety Plan for your facility.

For smaller animal food businesses:

Animal food facilities within this category will be required to implement and maintain CGMP standards outlined by FDA.  These standards focus upon fundamental food safety practices in regard to the manufacture of animal food.  Facilities will be required to ensure that daily operations limit possible food contamination from a variety of factors.

Staff in direct contact with food or food-contact surfaces should follow hygienic practices such as consistently washing hands and removing jewelry that could fall into batches of food.  Facility grounds should be properly maintained and free from litter and waste to exclude pests.  Additionally, the construction and layout of facilities should allow for proper cleaning, maintenance, and pest control, while taking measures to prevent potential contamination of food from factors such as condensation dripping off of pipes or fumes that need proper ventilation.

Not sure if your facility is properly following CGMP requirements?  Registrar Corp’s Food Safety Specialists can perform a Mock FDA inspection that identifies potential food safety violations and educates facility staff on FDA expectations.  Mock Inspections are included in Registrar Corp’s U.S. Agent service at no charge, aside from travel and lodging costs.

Registrar Corp assists companies with FDA compliance.  Our Regulatory Specialists are knowledgeable and experienced in the various aspects of FSMA and can help your food facility take the necessary steps to meet FDA’s extensive food safety requirements.  For more information, please call +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Has Started Inspecting U.S. Importers for FSVP Compliance

As of May 30, 2017, most U.S. importers of food and beverages for human and animal consumption are required to comply with the U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Program (FSVP) rule.  Since the compliance deadline, Registrar Corp is aware that importers have begun receiving emails from FDA with the subject line: “FSVP Inspection Requirements, Handouts & Law.” This email informs importers of an upcoming FDA inspection to examine their compliance with FSVP requirements.  In light of these recent events, Registrar Corp provides importers with pertinent information to be prepared for a possible FSVP inspection.

What is a FSVP?

The FSVP rule requires U.S. importers of food and beverages to designate a “Qualified Individual,” defined by FDA as possessing either appropriate training or job experience reflecting the ability to develop a food safety system, to develop FSVPs for each food from each foreign supplier.  This means that multiple foods from a single supplier or multiple units of a single food from multiple suppliers each require individual FSVPs.  FSVPs require several components including hazard analysis, an evaluation of risk and supplier performance, documented supplier verification activities, and a plan for corrective actions should a supplier be found non-compliant.

In a single FSVP, a hazard analysis of the food item should be conducted, identifying any potential and foreseeable biological, chemical, or physical hazards that could cause illness or injury in the absence of preventive measures.  The importer should assess the probability and severity of the illness or injury should these measures not be implemented, while considering a diverse array of variables, such as manufacturing procedures, raw materials and ingredients, and the transportation, storage, and distribution of the food.

An evaluation of risk and supplier performance should consider the results of the hazard analysis while assessing the supplier’s food safety practices and procedures, its compliance with U.S. food safety regulations, as well as its history of correcting food safety problems to determine the level of health risk when importing from the supplier.  Importers should determine appropriate verification measures relative to the level of food safety risk the supplier poses.  Verification activities may include onsite audits, sampling, and/or review of the supplier’s food safety records.

Provided any food safety issues arise, an importer is required by FDA to take the proper steps toward correcting the issue with the supplier.  Corrective Actions may vary depending upon specific issues, and in severe cases, may require the importer ceasing business with the supplier until they are found compliant.  One such issue may be that a supplier is lacking a Food Safety Plan as required under the FSMA Preventive Controls rule.  Registrar Corp is experienced in the development of these plans and can assist the supplier in becoming compliant so both parties may continue business.

What Does a FSVP Inspection Look Like?

According to an interview with Sharon Mayl at FDA, FSVP inspections are not to be confused with traditional food facility inspections and consist of a document review. This review may examine whether an importer has detailed components required under the FSVP rule for the specified suppliers and food items.  The inspector may also look for evidence that FSVP procedures are followed between importer and supplier for the food items in question and that the importer is documenting appropriate analyses and verification activities, reviewed by a Qualified Individual.

Registrar Corp’s Regulatory Specialists can assist in developing appropriate FSVPs for your food items.  Additionally, Registrar Corp’s FDA Compliance Monitor can monitor suppliers’ compliance history as required under the rule and can serve as proof of compliance during a FDA FSVP inspection.

Registrar Corp assists food and beverage companies with FDA compliance.  For more information or assistance with specific FSVP requirements, please call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

U.S. FDA Announces Reinspection Fees Fiscal Year 2018

The U.S. Food and Drug Administration (FDA) recently published the hourly rates for the reinspection of food facilities during fiscal year (FY) 2018.  The cost of reinspection for a domestic facility is $248 per hour, a $27 increase from FY 2017.  The cost for a foreign facility is $285 per hour, the same as in FY 2017.

The total cost of a reinspection depends upon the amount of time FDA performs inspection-related duties.  This may involve preparation for the inspection, travel to and from the facility being inspected, the physical examination of the premises, and any sample analysis or lab work required.  Reinspection fees can quickly add up to thousands of dollars, especially for facilities in countries where travel alone can take a day’s time. To avoid these potentially high reinspection fees, it is prudent to take measures to ensure that proper food safety procedures are in place when FDA inspects a food facility the first time.

What is a reinspection?

When a food facility registers with FDA, it grants FDA permission to inspect the facility at any given time. Initial FDA food facility inspections are of no cost to the facility and may occur due to routine reasons, a facility’s level of potential risk to public health, or as a response to a problem or complaint.

If FDA discovers certain food safety violations during an initial inspection, the Agency may decide it needs to return at a later date to evaluate whether the facility implemented appropriate corrective actions.  This second evaluation is considered a reinspection (also sometimes referred to as a “compliance follow-up inspection”).

The frequency at which initial FDA inspections occur may continue to increase in response to mandates under the 2011 Food Safety Modernization Act (FSMA).  FSMA directs FDA to inspect domestic facilities at a rate determined by the risk its products pose to public health.  High-risk facilities are to be inspected every three years, while low-risk facilities are to be inspected every five years.  FSMA also directed FDA to increase its annual inspection of foreign facilities. FDA provides foreign facilities with notice that an inspection of the facility will occur.  Domestic facilities may receive no notice at all.  Regardless, it is crucial for all facilities to take steps to be prepared for the initial FDA inspection at all times.

What factors could warrant a reinspection?

FDA’s most recently published data on commonly occurring inspection violations at food facilities indicates food safety issues that FDA may likely search for while inspecting a facility. The most frequent violations in FY2016 included:

  • Lack of Effective Pest Exclusion / Screening – FDA cites a facility for not taking effective preventative measures against pest presence in food processing areas or not implementing controls to protect food from contamination due to pests.
  • Sanitation Monitoring – FDA cites a facility for failing to effectively monitor sanitation practices and conditions consistently.
  • Floors, Walls, and Ceilings – FDA cites a facility for being constructed in a way that inhibits proper sanitation and repair of the floors, walls, and ceilings.
  • Importer Verification – FDA cites a seafood importer for failing to document verification of a supplier’s compliance with Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations.
  • HACCP Plan Implementation – FDA cites a facility for failing to implement procedures established in its written HACCP Plan. It is important to note that following the compliance date in September 2016, FDA is now likely to also check for proper implementation of Hazard Analysis and Risk-based Preventative Control (HARPC) Plans at most food facilities.

Several violations in the above list were just as frequent in 2015 as they were in 2016.  Registrar Corp urges food facilities to examine these issues and take the appropriate measures to prevent FDA citations for these and similar food safety problems.

Proper preparation for an initial inspection may reduce the chance of FDA citing a facility for violations that can cause return visits. Having a third party trained in FDA inspections review your facility for violations is often an invaluable business decision. Poor results from an initial inspection not only can result in an expensive reinspection, but also in Warning Letters and other public information that could damage a brand’s reputation. While there may be costs associated with third-party assistance, it is likely more affordable than the alternative.

Registrar Corp offers a Mock FDA Inspection service in which our Food Safety Specialists identify potential food safety problems and educate staff on FDA expectations.  This Mock FDA Inspection service is included as part of Registrar Corp’s U.S. Agent service at no charge, aside from lodging and travel expenses.

For questions or assistance with FDA compliance, call Registrar Corp at +1-757-224-0177.  Additionally, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.