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Sellers of Laser Products Must Have A FDA Accession Number

Online vendors such as Amazon require documentation of a U.S. Food and Drug Administration (FDA) accession number for certain laser products sold through their online platforms.  An accession number is a unique identifier that FDA uses to track reports from specific models of radiation-emitting electronic devices (RED).  FDA requires manufacturers of certain RED products to have an accession number for their product prior to marketing it in the United States.

How Do I Get an Accession Number for my Laser Product?

In order to obtain an accession number, FDA requires manufacturers of most laser products to submit a product report consisting of numerous aspects including:

  • Identifying information for the product and manufacturer
  • Information on components and accessories, as well as functions and uses that may affect the product’s radiation emissions
  • Measures taken to control levels of radiation in the product
  • Warning statements and instructions for use related to the product’s radiation safety

After a manufacturer submits a report, FDA issues an acknowledgement letter containing the product’s accession number.  The letter does not constitute FDA approval of the device.

When a business has an accession number for a laser product, FDA further requires annual reporting for the product to be submitted by September 1st of each year.  Among other aspects, annual reports must contain a description of quality control procedures for the device, as well as test results and copies of communications relating to radiation safety of the device.

FDA reporting requirements apply to most laser products a business may want to sell through online vendors.  Even products as seemingly harmless as spinning tops with laser lights and laser cat toys are subject to reporting.  Failure to report may not only prohibit the sale of your product through Amazon and similar platforms, but may also result in detention of your shipments at the U.S. border.

For companies considering selling laser products through Amazon, Registrar Corp’s Regulatory Specialists can help determine the specific requirements for your product and facilitate reports with FDA.  If you are located outside of the United States, Registrar Corp can also serve as your U.S. Agent for Service of Process.  Simply complete the form below or call us at +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Issues Guidance on Medical Device Accessories

Medical device manufacturers commonly question whether the U.S. Food and Drug Administration (FDA) considers their product a medical device “component” or “accessory.”  Given that accessories can be classified separately from the parent devices they function with, the distinction is important.  In December, FDA issued a guidance on accessory classification policy that helps clarify this distinction.

Component or Accessory?  What is the Difference?

CFR 21 820.3(c) defines a “component” as “any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.”  For example, a stethoscope contains multiple parts, including a diaphragm, bell, and tubing.  When packaged in whole with the stethoscope, these parts would be considered medical device components that comprise a finished medical device.

In contrast, FDA clarifies that an “accessory” is a separate, finished device intended to “support, supplement, and/or augment the performance” of at least one parent device.  Accessories might be marketed individually for use with a specific device type and may be a different class than their parent device.

For instance, an endoscope, which is used to examine a patient’s internal organs, receives its own medical device classification.  An individually marketed endoscopic snare may be attached in order to remove harmful objects from a patient during endoscopy.  Because the snare is marketed for intended use with a parent device and it supplements the parent device by adding functionality, the device would likely be considered an accessory.

Likewise, cushions for motorized wheelchairs are often marketed separately with the intent to address specific physiological concerns of the device user.  The cushion augments the parent device by improving convenience for the device user.  While the motorized wheelchair may be a class II device, the cushion may present lower risk when used with the parent device.  Dependent on FDA’s assessment of this risk, the cushion might be considered a class I medical device accessory, subject to different requirements than its parent.

FDA’s New Accessory Classification Process

FDA generally determines classification of accessories in one of two ways.  An accessory may be included in the same classification as its parent device through 510(k) Premarket Notification, Premarket Application, or express inclusion in the classification regulation of the parent device. Other cases may involve the issuance of a separate classification regulation when FDA considers an accessory to have a different level of risk than its parent device.

The FDA Reauthorization Act of 2017 allows for the classification of accessories based upon the level of risk posed when used as intended and the level of regulatory controls necessary to provide reasonable assurance of safety and effectiveness.  Manufacturers may now submit an Accessory Classification Request to FDA to receive appropriate classification of their device accessory.  An Accessory Classification Request includes a proposal to FDA that, among other aspects, identifies the accessory, the proposed class of the accessory, and the necessary information to establish the risk the accessory poses.

Medical device classification serves an important role in deciding a device’s FDA requirements, such as the premarket processes it may be subject to or when it is required to comply with certain regulations.  Lower device classes may even receive exemption from certain premarket requirements.

For proper accessory classification, Registrar Corp’s Regulatory Specialists can guide you through compiling the documentation required for a FDA Accessory Classification Request.  Additionally, if you manufacture an accessory and would like to preserve trade secrets from the manufacturer of the parent device, we can assist in the submission of a Medical Device Master File to FDA.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Removes Expired Drug Establishment Registrations and Uncertified Listings from its Database

On January 2, 2018, the U.S. Food and Drug Administration (FDA) removed all drug establishments that did not renew their FDA registrations for 2018 from its active registration database. The Agency also removed all uncertified drug product listings from publication.

  • FDA removed 1,256 of the 10,496 drug establishments in FDA’s database as of December 31, 2017 (12%)
  • FDA removed 30,786 of the 118,255 drugs listed in FDA’s database as of December 31, 2017 (26%)

Companies that would like to verify that their drug establishment registrations or drug product listings are active with FDA can do so at no cost using the following links:

Annual FDA Drug Establishment Registration

FDA requires registered drug establishments to renew their registrations between October 1 and December 31 each year.  Those that fail to renew by the deadline are removed from FDA’s database, and drugs manufactured in unregistered facilities are considered misbranded.  Marketing misbranded drugs in the USA is a prohibited act that may be met with seizure and injunction.

Registrar Corp can verify whether your registration was properly renewed at no cost.  Verify your registration now.

New “Blanket No Change Certification” Requirements for Drug Product Listings

FDA requires drug establishments to report any changes to product listings in June and December each year.  Until recently, unchanged listings required no action.  FDA introduced a change for the 2017 renewal period requiring registered drug establishments to submit a “blanket no change certification” in structured product labeling (SPL) format for all drug listings that required no updates within the year.  Unchanged listings that were not properly certified during the 2017 renewal period were removed from publication, making it a prohibited act for those products to be marketed in the USA.

Registrar Corp can verify whether your listings are currently on file with FDA at no cost.  Verify your listings now.

Registrar Corp is a U.S. FDA consulting firm that helps drug establishments comply with FDA regulations.  Registrar Corp assists with FDA registration, drug product listings, drug labeling, drug master files (DMFs), and more.  For questions or assistance, visit www.registrarcorp.com, call +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.

2017 in Review – U.S. FDA Medical Device and Drug Regulations

The medical device and drug industries saw numerous regulatory developments in 2017.  The U.S. Food and Drug Administration (FDA) introduced new requirements, fees, deadline extensions, and exemptions.  Below, Registrar Corp provides an overview of regulatory highlights this year.

FDA Removed Medical Device and Drug Establishments that Did Not Register for 2017

Medical device and drug establishments that failed to properly renew their registrations for 2017 were removed from FDA’s active registration database. The Agency will likely do the same in 2018.  Marketing medical devices and drugs without a valid registration is a prohibited act that may be met with seizure and injunction.

FDA Extended the UDI Compliance Date for Class I Devices to 2020

FDA issued a letter in June announcing its intention to extend the universal device identifier (UDI) compliance dates for class I and unclassified devices.  The letter proposes to push the UDI labeling compliance date for these devices to September 24, 2020.

FDA Exempted Certain Class II Devices from 510k

In July, FDA exempted certain class II medical devices from premarket notification (510k) requirements. The exempt devices “are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.”  View a list of the exempt devices here.

The Compliance Date Passed for the Consumer Antiseptic Wash Final Rule

As of September, over-the-counter (OTC) consumer antiseptic washes containing any of nineteen certain ingredients are not permitted to enter interstate commerce without approval of a new drug application (NDA).  FDA made this determination after discovering there was insufficient evidence to support the ingredients’ safety and effectiveness for their intended use.

FDA Published FY 2018 User Fees for Medical Devices and Generic Drugs

The Medical Device User Fee Amendments (MDUFA) and Generic Drug User Fee Amendments (GDUFA) were reauthorized for fiscal year (FY) 2018.  The amendments introduced differences in rates from FY 2017, as well as new types of fees for certain facilities and submissions.

View the list of fees for medical device establishments here.

View the list of fees for drug establishments here.

FDA Introduced a New Verification Requirement for U.S. Agents of Medical Device Establishments

The U.S. Agent of medical device establishments located outside of the United States is now required to confirm this role with FDA.  Agents must accept their designation through the FDA Unified Registration and Listing System (FURLS).  If the Agent does not respond to a verification email within ten days, the establishment will need to designate a new Agent.

FDA Introduced Annual Certification Requirement for Unchanged Drug Listings

The 2017 registration renewal period introduced a requirement for drug establishments to submit a “blanket no-change” certification for drug listings that did not receive any changes to data or labeling during the year.  Certifications must be submitted in structured product labeling (SPL) format.

FDA Published Final Guidance for UDI Direct Marking Requirements

In November, FDA issued a final guidance to clarify a device labeler’s responsibilities for UDI direct marking requirements.  Class II devices must comply with direct marking requirements by September 24, 2018.  During a December webinar, FDA stated that they do not intend to enforce these requirements for class I and unclassified devices until September 24, 2022.

FDA Issued a Final Rule on the Safety and Effectiveness of Triclosan in Health Care Antiseptics

FDA finalized a rule prohibiting the use of Triclosan and 23 other active ingredients in OTC antiseptics for health care environments.  After December 20, 2018, health care antiseptics containing these ingredients will not be permitted to enter interstate commerce without FDA approval of an NDA.

As we cross into 2018, Registrar Corp will continue to keep the medical device and drug industries informed about important FDA regulations.  For assistance with FDA requirements in either industry, call us at +1-757-224-0177, or chat with a Regulatory Advisor 24/7 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 Issues Final Rule on Safety and Effectiveness of Triclosan in Health Care Antiseptics

On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments.  Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will not be permitted to enter interstate commerce without FDA approval of a new drug application (NDA).  You will find a list of the covered ingredients below.

The scope of this rule only applies to antiseptic products (i.e. washes, scrubs, rubs, and skin preparations) used by health care professionals in health care settings.  Antiseptic products intended for use by consumers are covered by two separate rules, one of which had a compliance deadline in September 2017.

Why are these ingredients prohibited?

The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products.  A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products.  FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).

FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine.  The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.

Not sure how this rule applies to your health care antiseptics?  Registrar Corp’s Regulatory Specialists can conduct a full review of your antiseptic product’s ingredients and labeling.  We review your product’s active ingredients to ensure that they conform to the requirements specified in the applicable FDA monographs for antimicrobial drug products. We also inspect your labeling to ensure that its content and formatting conform to numerous FDA drug regulations.  In addition to an extensive report of suggested revisions, you will receive a print-ready label incorporating these changes.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Health Care Antiseptic Final Rule:

Chlorhexidine gluconate
Mercufenol chloride
Methylbenzethonium chloride
Secondary amyltricresols
Sodium oxychlorosene
Iodophors (Iodine-containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Iodine tincture USP
• Iodine topical solution USP
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Undecoylium chloride iodine complex
Triple dye
Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol

FDA Announces New Enforcement Approach to Drugs Labeled as Homeopathic

Once small and specialized, homeopathic drugs now comprise a nearly $3 billion industry.  Following an increase in reported health concerns stemming from these products and a flurry of unsubstantiated health claims surrounding the industry, the U.S. Food and Drug Administration (FDA) is taking new measures to curb the widespread distribution of potentially harmful drugs labeled as homeopathic.

What are Homeopathic Drugs?

Homeopathy is a form of alternative medicine based on the principle of remedying health conditions using diluted solutions of substances that produce similar symptoms in a healthy patient.

The Food, Drug, and Cosmetic (FD&C) Act defines articles recognized in the official Homeopathic Pharmacopoeia of the United States as drugs.  FDA states that homeopathic drugs “are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.”

Despite this, the uniqueness of homeopathic drugs delayed them from the 1972 over-the-counter (OTC) drug review, which determined the safety and effectiveness of most OTC drugs on the U.S. market.  Even now, FDA has not conducted a formal review of homeopathic drugs.  Since 1988, a FDA Compliance Policy Guide (CPG) establishes provisions under which these products may be marketed without the prior FDA approval required of other drug products.

Why is FDA Cracking Down on Homeopathic Drugs?

Numerous homeopathic drugs contain potentially harmful ingredients.  As recently as September 2017, a homeopathic drug facility received a Warning Letter, citing failure to establish adequate in-process controls for products containing multiple potentially toxic ingredients.  One such ingredient was Nux vomica, a plant bearing constituents commonly used for rat poison.

Throughout 2017, FDA issued at least four additional letters to homeopathic drug manufacturers who failed to adequately test and control potentially toxic substances in their products.  FDA charged the drugs in question as adulterated.

New Enforcement Approaches to Homeopathic Drugs

In addition to FDA, the U.S. Federal Trade Commission (FTC) has issued measures to mitigate the prevalence of unsubstantiated health claims made by homeopathic drug manufacturers. A 2016 FTC Enforcement Policy Statement requires homeopathic drug labeling to communicate that “there is no scientific evidence that the product works.”  The label must also indicate that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”

A December 2017 FDA draft guidance explains that the Agency intends to prioritize enforcement on products that are known to cause harm to patients, including those with reported health issues and those deemed adulterated under section 501 of the FD&C Act.

FDA states it will also focus increased attention on homeopathic drugs with less overt health concerns.  According to the guidance, unapproved drugs intended to treat serious or life-threatening conditions may cause a patient to delay or discontinue treatment already generally recognized as safe and effective (GRASE). Homeopathic drugs designed for vulnerable populations (e.g. infants and the elderly) may pose significant health risks even in small concentrations, in spite of treatments that have already been determined GRASE.  For this reason, these drug categories may see increased regulatory enforcement.

In the previously referenced Warning Letters, FDA maintains that “nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.”  The letters and newly issued guidance suggest that FDA intends to expand efforts to hold homeopathic drug manufacturers accountable to the regulations derived from the FD&C Act.

Registrar Corp is a consulting firm that assists drug companies with U.S. FDA regulations.  Our Regulatory Specialists can assist with FDA registration and drug listing, labeling requirements, and other drug regulations.  For assistance or questions call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Upcoming Changes to FDA Electronic Medical Device Reporting (eMDR) in 2018

Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury.  An “adverse event” is when a device has a malfunction that could cause death or serious injury.  Importers report this information to the manufacturer.  The U.S. Food and Drug Administration (FDA) has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018.

The Agency will replace the codes for FDA Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion with similar codes established by the International Medical Device Regulators Forum (IMDRF).

IMDRF has released public references to help map FDA codes to the new codes during the interim before the update.  For example, the current FDA Device Problem Code 2682 refers to an “issue associated with the interaction between the patient’s physiology or anatomy and the device that affects patient and/or device.” This code corresponds to and will be replaced by IMDRF code A0101, a “problem associated with the interaction between the patient’s physiology or anatomy and the device that affects the patient and/or the device.”

Despite this mapping, reporting parties will not be able to rely on FDA codes after the update.  Some IMDRF codes do not have a current FDA equivalent, and FDA has further stated that the submission of retired FDA codes following the update will be rejected by the eMDR system.   As such, reporting parties should familiarize themselves with the IMDRF codes for a smooth transition into these changes.

If you are a reporting party in need of assistance, Registrar Corp can guide you through the eSubmitter software and facilitate your Adverse Event Report submission to eMDR.  Registrar Corp offers Adverse Event Reporting assistance at no fee to clients of our U.S. Agent Service.  Call us at +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24 hours a day 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.


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