The Food and Drug Administration (FDA) recently issued Guidance that describes circumstances that could occur during a drug facility inspection that might be deemed to constitute a “delay,” “denial,” “limitation,” or “refusal” of an inspection. The Guidance stems, in part, from Sec. 707 of the Food and Drug Administration Safety Improvement Act, which permits the FDA to deem a drug to be “adulterated” when it “has been manufactured, processed, packed or held in any factory, warehouse, or establishment and the owner, operator or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” To read the Guidance, click here.
We recommend that FDA-regulated drug establishments consider the Guidance closely and revise their written internal procedures as necessary to specifically address the inspectional issues noted in the Guidance.
However, while the Guidance focuses on policies related to drug inspections, a footnote seeks to extend the scope of the Guidance to “facilities subject to inspection under any of the authorities in Sec 704 of the [Food, Drug, and Cosmetic] Act,” which also includes inspection of food, animal drug, medical device, tobacco, and cosmetic facilities. Thus, the FDA is saying that the Agency may very well apply the Guidance to all facilities subject to its inspection authority, though the authority for this extension of inspectional authority is highly questionable.
The Guidance provides, in part, the following examples of what the FDA might consider to be attempts by a firm to delay, deny, limit, or refuse an inspection:
- Delays due to lack of responsiveness by the company in scheduling an inspection after receiving notice from the FDA and delays that occur during the actual inspection, such as a failure to provide the inspector with access to the facility in a timely manner, or access to documents in a timely manner.
- Failure to allow an inspector access to the facility without certain company staff being present.
- Limiting an inspection by denying the FDA investigator use of a camera during the inspection; or denying access to records; or discontinuing manufacturing during an inspection without justification.
- Refusing an inspection by baring an FDA investigator from entering the facility.
Perhaps most controversially, the FDA states in the Guidance that it has the authority to take photographs during facility inspections. Indeed, the Guidance goes so far as to state that “impeding or resisting photography by an FDA investigator” during an inspection may be considered to be an “unreasonable limitation” when such photographs are considered to be “necessary” to the conduct of the investigation. Nothing in the Federal Food, Drug and Cosmetic Act gives the FDA authority to take any photographs during an inspection and there is a very real issue over whether the Agency can arrogate to itself such authority by simply issuing a Guidance that says so.