A businesswoman discovers how refusing an FDA inspection can earn an Import Alert 99-32 and a spot on the FDA Red List.
Author

Fabiola Negron

Director of Food Safety

Import Alert 99-32: What Happens If I Refuse FDA Inspection?

Mar 25, 2024

Facilities located outside the U.S. that refuse an FDA inspection may be placed on Import Alert 99-32: Detention Without Physical Examination (DWPE) of Products from foreign establishments refusing FDA inspection.

Not only does this import alert allow the Administration to seize your items, it places your establishment on an FDA Red List. Any products from facilities added to the Red List are subject to refusal of admission according to section 807 B of the FD&C Act until the facility has documented proof of an inspection.

What is an Import Alert?

Import Alerts occur when the Food and Drug Administration (FDA) notices a pattern of non-compliance from a particular company, country, or product type. They inform both FDA’s field staff and the general public that the Administration has enough evidence to permit DWPE of products that appear to be in non-compliance and violation of FDA regulations.

Delayed or refused shipments resulting from Import Alerts and their respective FDA Red List can strain relationships with buyers, damage a brand’s reputation, and can greatly affect revenue.

We strongly advise establishments to accept an inspection without hesitation.

FDA may issue a Notice of Inspection at any time. You should prepare by assuring your facility is compliant with FDA Current Good Manufacturing Practices (cGMPs) and other regulatory requirements as other violations may warrant further field examination.

What is the Purpose of an Import Alert?

Import alerts are intended to help prevent products suspected of FDA violation from being distributed in the United States. They free-up agency resources for the physical examination of products from other shipments. Import Alerts also provide uniform coverage across the country.

Import Alerts also place responsibility firmly with the importer. This is to assure that products being imported into the United States are in full compliance with all FDA’s laws and regulations.

What Types of Import Alerts Are There?

A product can be placed on an Import alert based on how the product is made or based on issues with the product itself.

Import alerts are usually categorized as:

Country or Area Wide

FDA may detain without physical examination various products intended for distribution in the U.S. from a specified country or area. For example:

  • Import Alert 12-03, DWPE of Imported Soft Cheeses and Soft Ripened Cheeses from France.

Country or Worldwide

FDA may also detain without physical examination certain products from any and all countries outside of the U.S. for various reasons such as:

  • Import Alert #16-20, DWPE of Puffer Fish.

Due to the fact that the toxins in Puffer Fish cannot be destroyed by cooking or freezing, FDA restricts import of this product from any and all sources, worldwide.

Shipper

Products from various shippers may also be subject to DWPE by FDA due to factors such as contamination or adulteration. An example:

  • Import Alert #16-105, DWPE of Seafood and Seafood Products from a specific manufacturer or Shipper due to Histamines.

Manufacturer & Product Specific

As with the case of Import Alert 99-32, FDA also retains the right to detain without physical examination specific products from a manufacturer. Other examples of this include:

  • Import Alert 89-16, DWPE of Products from Medical Device Firms that refused FDA Inspection.
  • Import Alert 99-37, DWPE of Low-acid Canned Foods and Acidified Foods that do not have Filed Scheduled Processes.

FDA Inspections of Foreign Food Facilities

FDA requires food facilities to respond to inspection requests within 24 hours and the Agency may interpret a lack of response as refusal of inspection. It’s also important to keep in mind that FDA communicates an inspection request with a facility’s U.S. Agent in charge. It’s prudent to designate a reliable Agent to avoid miscommunication or late responses.

When preparing for an inspection, it is sound strategy to familiarize yourself with common FDA violations so you can assure the same mistakes aren’t made at your facilities.

For customized preparation assistance, Registrar Corp can dispatch a Food Safety Specialist to your facility to conduct a Mock FDA Inspection. As part of this inspection service, our Specialist will help identify potential food safety issues in the structure, processes, procedures and documentation used in your daily production.

What to Do When You’re on FDA Red List for Import Alert 99-32

To be removed from an Import Alert 99-32 and its red list, a facility is required to petition for FDA inspection. FDA states that it may be at least a year before FDA can return to inspect a facility that initially refused. Given this, full cooperation with FDA inspection is critical in avoiding loss of revenue from an otherwise avoidable Import Alert.

To remove a brand’s product from the FDA Red List, information should be provided to the Agency to demonstrate that the firm has completed FDA inspection and meets the criteria for removal. The process requires you to provide sufficient evidence of your corrective actions. It may also require multiple compliant shipments to be reviewed by FDA’s Division of Import Operations.

Registrar Corp has spent the last two decades helping over 30,000 companies each year across 190+ countries navigate the complexities of FDA compliance.

We know how to help you submit the most complete and evidence-based petition for removal and keep your products out of detention.

Discover how Registrar Corp helps keep your business off Import Alerts and avoid disruptions.

Author


Fabiola Negron

Director of Food Safety

Widely respected in the Food Safety industry, Fabiola provides insightful education to food and beverage companies worldwide on U.S. FDA regulations resulting from the passage of the Food Safety Modernization Act (FSMA) in 2011. Her expertise in creating and reviewing Food Safety plans, helping U.S. importers comply with Foreign Supplier Verification Program (FSVP) regulations, and leading our Food Safety team have helped hundreds of companies comply with FDA food and beverage requirements.

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