FDA resumes domestic inspections. Are you ready?

As recently reported, the FDA has resumed routine domestic inspections. This Gardner Law Regulatory Alert offers tips on how you and your team can get prepared for a visit from the Agency.

For now, "prioritized domestic inspections" will be pre-announced to FDA-regulated businesses. They are unlikely to happen in areas seeing a spike in COVID-19 cases. The Agency indicated in a recent press release, "[t]he FDA will identify regulatory activities that can occur within the given geographic region. The three main categories of regulatory activity at the county level will be: mission critical inspections only, all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population and resumption of all regulatory activities."

Are you ready for a visit from FDA? Here are some tips on how to prepare for your next FDA inspection.

• Expect an inspection every 2 years-this timeline may be disrupted by COVID-19.
• Be aware of past FDA Form 483s (inspectional observations), recalls, internal audits, training records and related documents.
• Implement and deploy an Inspections Policy/SOP that outlines all aspects of an FDA inspection, e.g., receipt of FDA Form 482 (notice of inspection), communications, conduct, tracking system, document requests, final meeting, addressing 483 inspectional observations, etc.

• The "host" (e.g., QA Director) greets the investigator, reviews their credentials, provides a short tour, explains company history.
• The FDA investigator will usually explain the purpose of the inspection (e.g., routine, for cause, pre-approval). If the investigator does not discuss the purpose of the visit, ask.
• Mobilize response team: back room and front room teams, scribe(s), runner(s), subject matter experts ("SME").
• Identify someone to accompany the FDA investigator at all times while at the company.

• The host needs to review everything before it is provided to FDA-stamp confidential as necessary.
• Document everything provided.
• Involve senior management.
• Involve staff with good communication skills; and if possible, keep hostile personalities AWAY from FDA.

• Products, methods, SOPs, complaint files, records.

• DO NOT LIE OR MISLEAD-lying to a federal agent violates 18 U.S.C. Sec. 1001 and carries severe penalties including prison (up to 5 years) and fines. Many famous prosecutions have occurred under this law, e.g., involving Martha Stewart, Rod Blagojevich, Scooter Libby, Bernie Madoff, and Jeffrey Skilling, just to name a few.
• Protect company interests at all times.
• Be professional and receptive to discussions involving possible flaws in your Quality Management System ("QMS") .
• Focus on positives rather than becoming defensive.
• Demonstrate compliance.
• If necessary, seek clarification of questions asked by the investigator.
• Keep track of any open items.
• Consider addressing (and resolving, if possible) observations as they arise.
• Provide requested documents promptly and know which documents you are not required to provide under the law (e.g., certain financial records).

• Provide the investigator adequate space to work.
• Be professional.
• It is acceptable to provide coffee and friendly conversation, but you do not need to be their pal.

• Have a "wrap-up" meeting with the investigator.
• Record meeting minutes.
• Ask the investigator if he/she will be back and when (likely to be there 5-7 days for a full QMS inspection).
• Debrief with the internal team to discuss "near misses," questions, concerns, etc.

• Have management present at meeting.
• Listen-do not try and explain away observations.
• Ask questions, qualify, etc.
• DO NOT SIGN ANYTHING. Politely decline-explain, "our policy is not to sign" and stop talking.
• The investigator may create an affidavit regardless of whether you intend to sign the document.
• Do not agree with any conclusions drawn by the investigator-doing so may be considered an "admission against interest".
• It is okay to ask for a copy of the Establishment Inspection Report ("EIR"), but it will likely not be ready.
• Okay to ask what FDA will recommend (NAI, VAI, OAI), but they may not answer:
  • No Action Indicated ("NAI")-least severe.
  • Voluntary Action Indicated ("VAI").
  • Official Action Indicated ("OAI")-most severe, Warning Letter (or worse) likely coming next.
• FDA will leave the 483-you do not have to sign this.

• Focus the attention of the response team on resolving any issues raised by the regulator.
• Consult your lawyer as necessary, e.g., perceived FDA overreach, escalation, and/or for assistance with the company response to the Agency.

• Refuse reasonable requests.
• Respond to questions you do not understand.
• Provide false or misleading information (same as lying).
• Blow up or be petty.
• Use absolute words, e.g., never, impossible, always.
• Go on and on, or volunteer unnecessary information. Answer the question that was asked and stop talking.
• Have uninformed and/or hostile individuals interacting with the Agency.
• Guess the investigators intent for a question.
• Deliberate with your peers in front of FDA.
• Take observations personally.
• Panic!

One of our team members is a Biomedical Engineer and former FDA Compliance Officer of 33 years. Here is a tip from him on responding to questions from the FDA: T-L-A-S-T.

T = Tell the truth.
L = Listen to questions and understand them before answering.
A = Answer the question clearly and concisely.
S = Stop after you answer the question.
T = Tell the truth.

If you need help preparing for, or reacting to, an inspection (from FDA or another regulatory authority), Gardner Law can help. We routinely assist clients with FDA enforcement actions of all types. Our team includes experienced attorneys and former FDA staff. Our Quality team, led by Attorney and Quality Engineer Brynn Stanley, can assist you by performing mock audits, quality investigations, and answering your FDA-related QMS questions.