March 2006 Post Dinner Summary
When the FDA Comes Knocking Presented by Mark DuVal
Mark began his presentation by stating that you must have a healthy fear of the government. He further stated that this does not mean that you blindly allow the FDA investigator access to everything that they request or answer every question they ask.
The FDA has statutory and regulatory authority over food, drug and cosmetic products in this country. Their authority varies with the product. There are limitations to their authority. There are confidentiality and reasonableness provisions they must follow. For most audits, notification is given some time in advance of the audit. Not all records are subject to the audit, even though the investigator is liable to ask for more than you are required to give. Photographing your facility is a controversial area and permission should not be given. Do not prevent the examiner from taking pictures if he insists, note your objection to put it on the record of the audit. Failing to object can be taken as permission and you are then subject to the investigator’s findings.
Mark recommended that you prepare for the audit by reviewing the FDA manuals and guides that apply to you. Assign a non-confrontational escort to the investigator. Set aside someplace for the investigator to use as a base during the audit. Arrange for top management to be available at the start and finish of the audit.
During the audit treat the investigator courteously but do not fawn over him. Provide the basics, office services, coffee, et cetera while avoid anything that might be seen as trying to curry favor. Be eager to resolve issues. If possible, try to resolve some while the audit is still in progress. Do not commit to more than is possible. If a problem is going to take months to resolve, don’t commit to a few weeks. Try to get daily debriefings from the investigator. On the defensive side of things, do not read or sign affidavits. Do not volunteer information outside the purvey of the audit. The results of the audit can lead to warning letters, civil remedies, product recall, criminal prosecution and the FDA’s most powerful tool, adverse publicity. They have the enforcement power to use these as warranted. Cooperation during the audit and your willingness to resolve issues will help keep the actions less drastic.
Occasionally you will run into situations where you should have your lawyer present. These situations include:
- If the focus of the audit changes
- Preparing an FDA form 483 response
- If you receive a warning letter
- If a recall is under consideration
- Dealing with the press
- Preparing for legal proceedings.