How Food Companies Can Respond to FDA Form 483s and Warning Letters

FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators will likely prioritize the following:

1. Careful review and assessment of the company’s written food safety programs and verification records; and
2. Extensive microbiological sampling (swab-a-thon).

To ensure that an FDA inspection is successful, it’s advisable to complete the following tasks prior to the arrival of FDA investigators.

First, identify a space within the facility to host investigators when they arrive. This might be a conference room or a vacant office that is well-lit, comfortable, and equipped with sufficient area for inspectors to review voluminous records. The space would best be located in a relatively out-of-the-way area, free of noise and clutter, including any potentially relevant regulatory records.

Once you have identified a meeting place, select at least two individuals for each facility to serve as inspector liaisons. These individuals should be highly knowledgeable about compliance, well informed about company operations, and capable of effectively responding to any requests for information or records. To that end, it is important to ensure that the supporting records for each of the regulatory programs are organized and maintained in such a way that the designated individuals can immediately retrieve at least three months’ worth of records for FDA review. Although FDA requires the majority of these records to be maintained for at least two years, FDA investigators will typically ask only to review records for the preceding three months.

Next, ensure that any deviations and the concomitant corrective actions are documented clearly, precisely, and correctly. This means that all documents addressing deviations should include the root cause of the deviation, corrective actions taken to prevent recurrence and, if product safety was not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

Among the best ways to prepare for an FDA inspection is to conduct a mock inspection. This would typically entail hiring FDA consultants and/or attorneys who can visit your facility and play the role of an investigator. This sort of exercise would typically require consultants to review your programs and identify any regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure. 

Responding to Warning Letters and Form 483s

No matter how well prepared you are, it’s not always possible to avoid regulatory enforcement actions. In turn, when FDA issues a Form 483 or warning letter, it will be critically important to maximize your likelihood of success by responding effectively.

Most importantly, take the process seriously and respond comprehensively. This means that every written response should be accompanied by adequate supporting documentation. For instance, it is not enough to simply state in your response that you corrected a problem by “conducting additional employee training.” Rather, in addition to stating that you completed the training, FDA will expect to see an attached training log or other document establishing that the training was completed.

Next, do not be argumentative. You may disagree with an inspector’s observation or an allegation contained within a warning letter, but the response is rarely (probably never) the place to litigate that disagreement. The agency wants to know you are going to remedy the problems, and wants concrete information establishing proof that your products and processes do not pose a threat to public health. Your job is to provide clear and compelling evidence that your processes are safe, not that inspectors are misunderstanding the regulations.

After drafting the initial response, have your regulatory attorney work with you to fill in any gaps, add any regulatory language, and massage the particulars. Your responses to the agency might also be discoverable by opposing lawyers in the event of future litigation, whether related or not. Allowing an attorney to fine tune the responses will keep your company from making potentially damaging assertions that, while forthright and seemingly harmless, can be unfairly leveraged by skilled attorneys in the future.