FDA Inspections: Lesson 1 – Interviewing Employees

This is the first in a series of blog posts on tips for successfully handling an FDA inspection.  Using publicly available examples, these “lessons” will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.  

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDA’s policy position.  As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company “delays, denies, or limits an inspection, or refuses to permit an entry or inspection.”  FD&C Act § 501(j).  A foreign food manufacturer that “refuses to permit entry of [FDA inspectors} to inspect such factory, warehouse, or other establishment” can be subject to an import alert under section 807(b) of the FD&C Act.

But what exactly constitutes delaying, denying, limiting or refusing an FDA inspection?  FDA has published Guidance defining examples of circumstances applicable to a drug or medical device company, as well as separate Guidance applicable to foreign food manufacturers.   Much of the debate on this issue centers on whether FDA can take photographs during an inspection (see our previous blog post).  But a recent Warning Letter raises new questions for regulated companies on whether FDA can interview company employees, and if so, how companies should handle these requests during an inspection.

On December 17, 2024, FDA issued a letter to Brands International Corporation, a drug manufacturer located in Ontario, Canada, citing it for limiting and delaying FDA’s inspection based on the following conduct:

• The Quality Manager “shoving and shouting at our investigators for conducting the inspection without [his] presence”
• Laboratory staff refusing to open a drug stability chamber “based on [the Quality Manager’s] hostile behavior”
• Upon FDA asking questions of the Quality Control Supervisor, the Quality Manager “interrupted and stated that only he can explain and answer the requests”
• While FDA was interviewing an employee regarding mold samples, the Quality Manager “began berating the employee, who then left the room”

Although delaying, denying, limiting or refusing the drug inspection was not the only violation cited in the Warning Letter – it also included several cGMP violations and potential cosmetic violations – the “limiting the inspection” violation was listed first, and thus considered by FDA to be the most significant violation.

Very rarely have we seen a Warning Letter call out the behavior of a single individual, and no less the Quality Manager, who is the public face of the company to FDA during inspections, for being uncooperative and hostile to FDA and the company’s own employees.  Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect.  Note that the relevant Guidance document for drug manufacturers (like Brands International) is silent on the issue of employee interviews, but the Guidance applicable to foreign food manufacturers is explicit that FDA considers a company to have refused an inspection if it acted unreasonably in preventing the FDA investigator from talking to pertinent staff to collect evidence.

Examples of where we would generally consider preventing the FDA investigator from fully conducting an inspection include:

. . .

The owner, operator, or agent in charge refuses to allow the FDA investigator to collect evidence to document potential violations (e.g., to take photographs as necessary; to collect samples; talk to pertinent staff; or to collect food labels and labeling).

FDA Guidance, at 8 (emphasis added).  Now, guidances are generally not legally binding, unlike statutes or regulations.  But because this Guidance was specifically authorized by statute, it may carry more weight in a court.

To be clear, FDA cannot coerce employees to testify during an inspection – certainly every Law & Order fan is familiar with the Constitutional right to remain silent – and there is at least some doubt as to the Agency’s legal authority to interview any employee it wants during an inspection.   But it appears FDA will assert that it has a right to question employees, presumably under the statutory provisions cited above, and FDA has the leverage (even if not explicit legal authority) to pressure companies to make their employees available.

How should FDA-regulated companies handle interview requests during an FDA inspection?  As a practical matter, we recognize there are few FDA-regulated firms that are ready and willing to contest the Agency in court over this issue.  (If so, please call us.)  There are tactful ways to accommodate FDA’s request and set appropriate limitations to ensure FDA does not overstep its inspectional mandate.  First, companies should designate the personnel who are authorized to respond to FDA’s questions during an inspection.  Written procedures should clearly state parameters for discussions with FDA, including prohibiting FDA from conducting a private interview with an employee who is not properly designated.  If FDA asks for an interview of a non-designated employee, companies can still be cooperative with the request but insist that designated personnel are present during those interviews and that FDA limit its questions to those that are directly within the employee’s job description and responsibilities.  Wholesale refusal to allow an employee to respond to direct questions from FDA only raises more questions and distrust from the FDA investigator.  Even if not cited in a Warning Letter, the FDA investigators are instructed to document in their Establishment Inspection Report incidents of hostile or uncooperative interviewees (see Investigations Operations Manual, at section 5.3.13), which can be publicly released.   Companies should train (and remind) employees on inspection readiness.

So Lesson #1, companies can control the extent in which FDA talks with personnel, but should do so based on established procedures and a cooperative attitude.