Compounding Pharmacy, Part 2: Preparing for an FDA Inspection

Pre-planning for an FDA inspection of your compounding pharmacy will help prevent rash decisions after the inspectors walk in the door.

Decide whether to let inspectors in.

If you decide not to let them in, they will typically get a court order and make their way into the facility sooner or later. This may simply prove to be an expensive delaying tactic that results in an antagonistic relationship. However, under certain circumstances, this may be the appropriate strategy. Nonetheless, barring the inspectors will typically escalate the situation and may lead to a more intense inspection featuring warning letters and/or subpoenas.

On the other hand, letting the inspectors in right away may help the pharmacy appear compliant and lead to less serious fines if problems are found. However, it is important to recognize that everything the inspectors observe once you let them in can and will be treated as evidence and may be used against you.

Have your war room ready.

Your planning should include setting up a war room in which key personnel can respond to inspectors’ requests, prepare the required documents, and monitor the inspection proceedings.

A war room plan will typically start by setting up 4 core teams: (1) a point of contact team, (2) an inspection team, (3) an agency response team, and (4) a media response team (for larger companies). Some or all of the following people may be present in your war room:

• The point of contact team typically consists of 1 or more people who are likely to first greet the inspector. The team’s members will be responsible for assembling the inspection team and sending out necessary information.
• The inspection team typically consists of a leader to consult with stakeholders, a spokesperson, a lawyer and/or regulatory person, and multiple note takers to create a record of all proceedings.
• Finally, the agency response team can include different people, depending on your decisions. It may include: a lawyer, pharmacist, manager, and/or technician representative. This team will likely come together to write a response to the FDA after the inspection.

Decide what information you will let inspectors have.

• Are you going to “waive privilege” for information that you don’t need to disclose?
• Have you marked and defined areas that are deemed a trade secret? How much access will you give the FDA to trade secret materials?
• Will you disclose financial information?
• Will the FDA have access to internal audit records?

Have standard operating procedures in place.

• Identify all non-essential personnel. Will these personnel be present during an inspection?
• Will your lawyers be present in the war room or the audit room?
• Do you have a template email ready to send out to inform employees when an inspection occurs?
• Have you had a discussion with employees to make them “audit ready”?
• Never leave the inspectors alone.

—Darshan Kulkarni and Samantha Ricketts

Darshan can be reached at (215) 703-7842 or by email at Darshan@conformlaw.com. You can also find him on Twitter @FDAlawyers.