Two recent developments regarding FDA inspection-related activities

The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and potential consequences they may face for failure to comply. First, on 22 October 2022, FDA published the Final Guidance for Industry on the Refusal of Inspection by a Foreign Food Establishment or Foreign Government (Final Guidance), where the agency outlines its expansive interpretation of when it considers a foreign establishment to have “refused” an FDA inspection under Section 807(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) . Such a “refusal” triggers FDA’s authority to refuse admission of food from the establishment into the United States. Second, FDA has published a handful of Warning Letters that the agency has issued to companies for regulatory violations the agency identified during a Remote Regulatory Assessment (RRA). The Warning Letters highlight that the agency has and will take enforcement action against a company if regulatory violations are identified during a voluntary RRA.

Final Guidance on Refusal of Inspection by a Foreign Food Establishment

Background

FSMA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to add Section 807(b), which provides that FDA must refuse admission of food into the United States “if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment.”¹Section 807(b) also provides that an owner, operator, or agent in charge shall be considered to have refused an inspection if they do not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after FDA submits an inspection request, or after a time period agreed upon with FDA.

Functionally, FDA uses Import Alert 99-32 (Detention Without Physical Examination of products from Firms Refusing FDA Foreign Establishment Inspection) to identify foreign food establishments that have refused an inspection (or whose government refused the inspection). Food offered for import from these establishments is subject to refusal of admission.

Refusal of Inspection

The Final Guidance provides information on how FDA interprets the phrase “refuses to permit entry … to inspect” a foreign food establishment.2 In explaining broadly what FDA considers a refusal to inspect, the Final Guidance states:

We consider the language in section 807(b) of the FD&C Act that states, “refuses to permit entry [of an FDA investigator] to inspect” and “does not permit an inspection” to include statements, actions, and passive behaviors that prevent or delay us from scheduling or fully conducting an inspection. Refusal also includes statements, actions, and passive behaviors intended to avoid inspection or to mislead or deceive the FDA investigator in a manner that prevents the investigator from conducting the inspection.

The Final Guidance goes on to provide numerous examples of situations that FDA may consider to be “refuses to permit entry…to inspect,” which include, but are not limited to:

Preventing or delaying the FDA from scheduling the inspection (e.g., by not responding to FDA within the 24-hour period after FDA submits a written inspection request or not agreeing to an inspection start date without giving a reasonable explanation);
Preventing the FDA investigator from entering the establishment (e.g., by sending staff home for the day without a reasonable explanation);
Preventing the FDA investigator from “fully” conducting an inspection by establishing unreasonable preconditions to allowing the inspection or by preventing or interfering with the completion of some aspect of the inspection (e.g., by refusing to allow the FDA to collect evidence to document potential violations, such as take photographs, talk to staff, collect food labels, or collect environmental samples);
Causing a delay after the inspection has begun that interferes with the FDA investigator conducting an inspection as is usual and customary (e.g., barring the FDA investigator from areas of the establishment where food is grown, harvested, manufactured, processed, prepared, packed, or held in that area of the establishment, or areas that may “impact these operations.” The Guidance does not specify whether this extends only to areas where food is manufactured for U.S. shipment, or if it extends to the full facility.)

Refusals by Foreign Governments

In addition to the activities above, the following are some of the key activities by a foreign government that FDA would consider refusal of inspection:

Denying an investigator entry into the country (e.g., denying a visa) without a reasonable explanation.
Refusing to allow FDA to schedule an inspection without providing a reasonable alternative date or time.
Delaying scheduling an inspection without a reasonable explanation for the delay.
Preventing FDA from entering the establishment.
Refusing inspection of specific types of food facilities.

Consequences of Refusal

As discussed above, the consequence of refusing an inspection is placement on the Red List of Import Alert 99-32. The FDA written request to schedule an inspection will explain the consequences of a refusal of inspection and, if an investigator believes that an agent in charge is refusing the inspection, the investigator will “make reasonable efforts to inform” the agent in charge of the establishment of the consequences of a refusal. An inspector or other FDA staff who identifies potential refusal of inspection situations will refer the information to agency management to determine whether to place the establishment on the Red List of Import Alert 99-32. FDA will notify the establishment of its decision. To be removed from the Import Alert, the establishment may either request and permit an FDA inspection or may contest FDA’s decision in writing. The Guidance does not specify, however, if there is any opportunity for an establishment to appeal FDA’s decision before it is put on the Red List. Additionally, FDA cautions that in some situations, it may be at least a year before FDA can return to inspect an establishment that refused and then later requests an inspection.

Where a foreign government has refused an inspection and the government maintains its refusal after further dialog with FDA, the agency will add each foreign food establishment for which the foreign government refused a request to inspect to the Import Alert. FDA will advise the foreign government that it will remove an establishment from the Import Alert when the foreign government provides FDA with written notification that it can schedule and inspect the establishment. If the foreign government sustains its refusal of multiple requests to inspect foreign food establishments in the country, FDA will ask the foreign government if its refusal applies to all establishments in the country. If so, FDA may include all foreign food establishments in the country on the Import Alert.

Changes from the Draft Guidance

Several food industry trade associations raised concerns about the Draft Guidance in comments in December 2017, including that the Draft Guidance expanded the meaning of “refusal” to behaviors that merely limit FDA during an inspection, inconsistent with the text of the statute, and that the refusal of admission of food from a facility that “limited” an FDA inspection was a disproportionate consequence. FDA did not revise the Final Guidance to address these concerns, and in fact, strengthened its initial positions in some instances. For example, notable changes between the Draft Guidance and the Final Guidance include the following:

Good Faith Exception: The Final Guidance removes a “good faith” exception from what would be considered a “refusal.” Specifically, FDA deleted the language: “minor delays that result from good faith efforts by the establishment to comply with our request generally would not be considered a refusal of inspection.”
Photographs: In the Draft Guidance, FDA stated that a foreign establishment’s refusal to permit FDA to take photographs constitutes a refusal to permit inspection, and stated in a footnote that failure to permit photography at a domestic inspection constitutes a refusal to permit inspection that may result in FDA obtaining an inspection warrant. The food industry raised concerns through comments that the FFDCA does not explicitly grant FDA the right to take photographs during inspections and many food companies have policies that prevent the taking of photographs in their facilities due to concerns over confidential commercial information and employee privacy rights. In the Final Guidance, however, FDA expanded upon and moved the text of the footnote into the body of the document, and, elsewhere, provided additional detail of what exactly the FDA investigator may photograph, stating: “the FDA investigator may take photographs as necessary to present an objective and contemporaneous representation of establishment conditions. Examples of conditions or practices effectively documented by photographs include evidence of rodents or insect infestation; faulty construction or maintenance of equipment or facilities; product storage conditions; product labels and labeling; manufacturing and various control records; employee practices contributing to contamination or to violative conditions; and visible contamination of raw materials or finished products.” Inclusion of photography in the Final Guidance further signals that FDA continues to interpret its statutory authorities as providing a right to take photographs.3

In sum, the Final Guidance considers a number of activities that merely limit the agency’s ability to conduct an inspection to constitute a “refusal,” which would trigger placing the establishment on Import Alert. Though the Draft Guidance focuses on foreign food establishments, it suggests FDA would consider the same actions by a domestic establishment to constitute a refusal of inspection. However, FDA has stronger enforcement authority against foreign establishments that refuse inspection than domestic establishments that may engage in the same activities because of its ability to refuse entry for imports.

FDA Warning Letters After a Remote Regulatory Assessment

Relatedly, FDA has recently initiated enforcement action against foreign facilities in a separate capacity that may have broader implications for domestic food facilities as well. FDA recently published the sixth Warning Letter the agency has issued to a company following an RRA records review. As a reminder, earlier this summer FDA published a draft guidance on the Agency’s expanded use of RRAs to review regulated establishments and/or their records.⁴ Although the draft guidance stated that the agency would not issue observations and an Form FDA 483 at the conclusion of an RRA (because an RRA is voluntary and not an “inspection”), the Guidance states that information collected from an RRA may be used to “support actions such as a…Warning Letter.”

All six Warning Letters were issued to foreign facilities for violations of FDA’s seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).⁵ Although some of the companies that received a Warning Letter failed to respond to the agency’s discussion items identified in their respective RRAs, in the Warning Letter published most recently, the company provided the agency with two submissions.⁶ The agency, however, concluded the responses were inadequate.

As a reminder, in its draft guidance regarding RRAs, FDA states that the information and documentation gathered during an RRA can be used to support actions such as a regulatory meeting, warning letter, import action, recall activity, or enforcement action.