Planning in advance for an FDA inspection of your compounding pharmacy will help prevent rash decisions after the inspectors walk in the door.
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:
Decide what information you will let inspectors have.
Have standard operating procedures in place.
—Darshan Kulkarni and Samantha Ricketts