The U.S. Food and Drug Administration (FDA) requires facilities that manufacture, process, pack, or store food for U.S. consumption to renew their FDA registrations between October 1 and December 31, 2018. During the renewal process, facilities located outside of the U.S. must also designate a U.S. Agent for FDA communications. The renewal will not be considered complete until the listed U.S. Agent accepts this designation.
It should be noted that renewing a registration is distinct from updating a registration, and even food facilities that registered with FDA as recently as September 2018 will be required to renew. Facilities should ensure they properly renew during this period so their FDA registrations remain valid for 2019.
What are the Consequences of Not Renewing?
FDA will cancel facility registrations that are not properly renewed during the impending Biennial Registration Renewal period. Failure to renew FDA registrations during the 2016 renewal period contributed to a 28% drop in the number of registered food facilities in early 2017.
Food exported to the U.S. by a facility with a canceled registration may be detained or refused at the U.S. port of entry. Any facility that markets food for consumption in the U.S. without a valid registration may also be subject to civil or criminal penalties.
Registrar Corp, a consulting firm specializing in FDA regulatory compliance, can properly renew your registration and can act as the U.S. Agent for facilities outside the United States. As part of our registration renewal service, companies receive year-round regulatory support, including FDA compliance monitoring of their facility, detention assistance, and more.
To learn more, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.
Registrar Corp added recalls to their FDA Compliance Monitor. Users can now view the recall history of their own company, their suppliers, and potential suppliers, including:
- The description of the recalled product.
- The recall classification (the level of health risk involved).
- The reason for the recall.
- The current status of the recall (ongoing, completed, etc.).
This capability will help businesses comply with the Food Safety Modernization Act (FSMA), which requires food facilities and US importers to monitor their food suppliers’ FDA compliance as related to food safety. Recalls can damage a brand’s reputation, disrupt supply chains, and delay production and are an important aspect of a facility’s compliance history.
In addition to recalls, the FDA Compliance Monitor includes the FDA inspection history, FDA import alert status, FDA warning letter history, and record of FDA-refused shipments for monitored facilities, making full compliance with FSMA’s monitoring requirements easier than ever before. Schedule a demo of the FDA Compliance Monitor now.
Users can access the FDA Compliance Monitor through MyFDA.com, a simple online portal that makes it easy for food and beverage businesses to manage their FDA compliance, including FDA registrations and prior notice submissions.
For more information about the FDA Compliance Monitor or FSVP monitoring requirements, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.
Very small businesses generally must comply with the U.S. Food and Drug Administration’s (FDA’s) Preventive Controls for Human Food Rule by September 17, 2018. Under this rule, very small businesses are eligible for exemption from some of the Preventive Controls requirements, including the requirement to maintain a written Hazard Analysis and Risk-based Preventive Controls (HARPC) plan and the requirement to maintain a written Supply-Chain Program. To take advantage of these exemptions, businesses must submit their first attestation to FDA by December 17, 2018.
Who Qualifies for the Exemption
Very Small Businesses: Businesses (including all subsidiaries and affiliates collectively) that have averaged less than $1,000,000 (adjusted for inflation) in global sales of food for human consumption plus the market value of unsold food inventory per year during the previous three calendar years
Other Qualified Facilities: Though FDA has stated that it expects most facilities that qualify for the exemption to be very small businesses, other facilities qualify if they possess both of the two following characteristics:
- Over the past three years, they have averaged annual sales of food for human consumption below $500,000 (adjusted for inflation)
- At least half of their food sales over the previous three years have been directly to local consumers, restaurants, or retail establishments that are located in the same state, same Indian reservation, or within 275 miles of the food facility in question
Registrar Corp’s free Qualified Facility Wizard can help you determine whether your facility qualifies for the exemption.
How to Claim Eligibility for an Exemption
In order to claim eligibility for an exemption, a qualified facility must notify FDA of its status by submitting Form FDA 3942a. Using this form, the owner, operator, or agent in charge of a food facility must attest that the facility in question meets the definition of a qualified facility and that the facility is either “addressing identified hazards through preventive controls and monitoring the preventive controls,” or “complying with applicable non-Federal food safety regulations, and notifying consumers of the name and complete business address of the facility where the food was manufactured or processed (FDA.gov).”
When to Claim Eligibility
Qualified facilities that began or will begin processing, packing, or holding food before September 17, 2018 must submit the relevant form by December 17, 2018. Facilities that will begin processing, packing, or holding food on or after September 17, 2018 must submit the relevant form before beginning operations. Facilities must resubmit attestation to FDA every two years during the biennial food facility registration renewal period, which begins on October 1st and ends on December 31st of each even numbered year.
Preventive Controls Compliance for Qualified Facilities
As mentioned above, qualified facilities that attest are exempt from certain requirements of the Preventive Controls rules, but not all of them. Qualified facilities must still:
- Refrain from selling adulterated food
- Adhere to Current Good Manufacturing Practices (CGMPs)
- Ensure that all individuals who manufacture, process, pack or hold food are trained in the principles of food safety and are qualified to perform their assigned duties
- Maintain detailed records of the food safety training received by workers
A very small business that does not notify FDA of its status as a qualified facility is fully subject to the standard requirements of the Preventive Controls Rule and, generally, must develop and implement a written HARPC Food Safety Plan and Supply-Chain Program by September 17, 2018.
The Preventive Controls Rule compliance deadlines for facilities that do not meet the definition of a very small business have already passed. Thus, many food facilities that have not yet developed and implemented a written HARPC Food Safety Plan and Supply-Chain Program are likely to be in violation of FDA regulations.
Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses that do not meet the definition of a qualified facility or do not intend to notify FDA of their status as a qualified facility to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet regulatory requirements.
Assistance with Attestation and Food Safety Plans
Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) and can develop or review a facility’s HARPC plan for FDA compliance. Registrar Corp’s Specialists can also provide guidance on qualified facility attestation to firms that designate Registrar Corp to manage their FDA registration or act as their U.S. Agent for FDA Communications. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
The U.S. Food and Drug Administration (FDA) has finalized a number of rules under the Food Safety Modernization Act (FSMA) that address topics such as:
- Preventive controls for human and animal food
- Foreign supplier verification programs
- Prevention of intentional adulteration of the food supply
- The registration of food facilities
Many of the deadlines for complying with FSMA rules have already passed. There are also multiple upcoming deadlines that covered businesses should be aware of. A summary of several important FSMA requirements and deadlines may be found below.
Rules On Preventive Controls For Human and Animal Food
Preventive Controls Overview
Under this rule, food facilities are required to establish a hazard analysis and risk-based preventive controls plan (HARPC), also known as a food safety plan, that identifies and analyzes potential hazards and specifies risk-based preventive controls that minimize or prevent identified hazards. Each HARPC plan must be developed by a Preventive Controls Qualified Individual (PCQI), defined as “someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system (FDA.gov),” and must be kept in the records of a given food facility.
Preventive Controls Deadlines
Different businesses face different deadlines for completing their HARPC plan. Compliance deadlines for most businesses have already passed. Very small businesses, defined as businesses with under 1 million dollars in average annual sales of human food or under 2.5 million dollars of average annual sales of animal food and businesses subject to the Pasteurized Milk Ordinance have until September 17, 2018 to comply. Generally, facilities that manufacture, process, pack, or store human or animal food for U.S. consumption are legally required or will soon be legally required to comply with this rule.
Preventive Controls Enforcement and Requirements
Most U.S. food importers must verify that their suppliers meet applicable FDA food safety requirements, including these Preventive Controls requirements. Therefore, a US importer may ask to review a supplier’s HARPC plan. In the event of an inspection, FDA is also likely to review a facility’s written HARPC plan.
Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet government standards. Registrar Corp’s Food Safety Specialists are PCQIs and can develop or review a facility’s HARPC plan for FDA compliance.
Rule On Foreign Supplier Verification Programs
Foreign Supplier Verification Program Overview
Under the Foreign Supplier Verification Program (FSVP) rule, U.S. importers must have a written FSVP that is developed by a qualified individual and documents that they have completed risk-based activities meant to verify that the food they import into the United States is produced in a manner that is consistent with U.S. safety standards. Among other things, FSVPs must include an analysis of hazards associated with imported products and their suppliers and a plan for conducting verification activities, such as annual supplier audits, testing and sampling imported products, or reviewing a supplier’s HARPC Food Safety Plan. As part of the supplier analysis, importers must monitor and document the FDA compliance status of each of their suppliers by tracking FDA warning letters, import alerts relating to food safety, and other FDA enforcement actions.
Foreign Supplier Verification Program Deadlines
Importers’ deadlines are based on factors such as the size of a foreign supplier, the nature of the importer, and whether the foreign supplier must meet various regulatory requirements. The deadlines for complying with this rule passed for most importers in May 2017 and March 2018. The deadlines for other importers are scheduled to occur on dates ranging from July 26, 2018 to July 27, 2020.
Foreign Supplier Verification Program Enforcement and Compliance
FDA has begun inspecting importers for FSVP compliance. In 2017, failure to develop an FSVP was cited by FDA 108 times. FSVP inspections are based upon a review of records. Though such inspections may take place at an importer’s place of business, FDA may also ask that an importer provide FSVP records electronically or by some other remote means that quickly delivers records to the agency.
Registrar Corp’s Food Safety Specialists can develop new FSVPs on behalf of importers or review existing FSVPs for compliance. Registrar Corp also offers a tool to assist with the supplier monitoring aspects of FSVP. In order to monitor supplier compliance on their own, an importer would need to routinely search each individual FDA database for each of their foreign suppliers. In order to make this process easier, Registrar Corp developed the FDA Compliance Monitor. Users simply submit the facility they would like to monitor and the FDA Compliance Monitor will reveal any FDA Import Alerts, Warning Letters, Import Refusals, Recalls, or Inspection Classifications related to the facility. Printable reports allow users to document the compliance of their monitored facilities per FDA’s requirements.
Rule For Mitigation Strategies To Protect Food Against Intentional Adulteration
Intentional Adulteration Overview
Under this rule, most food facilities that are required to register with FDA must develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility. Food Defense Plans should identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification.
Intentional Adulteration Deadlines
Most covered facilities must comply with FDA’s Intentional Adulteration rule by May 27, 2019. Small businesses (defined as businesses with fewer than 500 full-time equivalent employees) have one additional year to comply. If you are unsure of whether your business qualifies as small, you can read Registrar Corp’s earlier blog post on how FSMA defines small businesses. Very small businesses (businesses with less than $10,000,000 in average annual revenue) are exempt from most requirements under FDA’s Intentional Adulteration rule. In order to take advantage of this exemption, businesses must provide records to FDA proving their very small business status by May 27, 2021.
Registrar Corp’s Food Safety Specialists can develop or review a Food Defense Plan for compliance with FDA’s Intentional Adulteration rule.
Amendments to the FDA Registration Process
FSMA made significant changes to the FDA registration process. Food facilities are now required to provide an email address for registration and must assure that FDA will be permitted to inspect the facility under circumstances permitted by the Federal Food, Drug and Cosmetic Act.
Additionally, FSMA requires facilities to renew their FDA registrations during each even numbered year. For example, because 2018 is even numbered, food facilities will have to renew their registration later this year between October 1 and December 31. It is very important that facilities comply with renewal requirements. In 2017, FDA removed 28% of food facility registrations from its database. Many of these removals resulted from a failure to properly renew registration as was required in 2016.
Registrar Corp’s Regulatory Specialists can help facilities register or renew their registrations with FDA quickly and properly.
Responding to the Implementation of FSMA
FSMA imposes many complex requirements on food businesses. The deadlines for complying with these various requirements have already passed or will soon pass. Businesses should take measures to ensure that they are in compliance. One such measure would be to enlist the help of Registrar Corp’s Regulatory Specialists who have expert knowledge of FSMA and extensive experience in helping businesses comply with FDA regulations. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
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.
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 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.
The 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.
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.
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.