by Joe Famiglietti, Senior Consultant
Managing an FDA inspection of your establishment is a difficult task in itself, but how should you respond when the Investigator notes a potentially objectionable condition and pulls out a camera to photograph the situation. It may be the sighting of a rodent in your facility, a poor employee practice, or a flaw in a piping system that might cause cross contamination of a product. The FDA Investigator is trained by the agency to document such potential violations by photographing situations such as these. Hopefully, your company has written procedures providing guidance on how to handle FDA’s use of the camera during regulatory inspections.
Is it sufficient to simply post a sign in your reception area advising guests that photography is not permitted in your facility? Or, do you have the Investigator read a prepared statement at the onset of the inspection informing that guests are not permitted to use a camera in the facility? Should you allow the FDA to enter your facility knowing that they are carrying a camera?
If FDA insists on photographing a potential violation in your plant, should you simply refuse to let them do so, or is there another way of handling this uncomfortable situation? In an upcoming EAS Newsletter article, Ex FDA Investigator and Compliance Officer Joseph A. Famiglietti will discuss these issues and explain FDA policies and procedures regarding the use of photography during inspections. He will explain some of the potential consequences your firm might experience if FDA is denied use of the camera in your facility. Some alternative methods will be discussed on how to handle FDA’s desire for the use of photographs in your facility, as opposed to an outright refusal to permit camera use by the agency. The importance of obtaining appropriate legal advice will also be covered.