FDA Inspection: Photographs During an Inspection
The FDA asserts in its inspection manual its right to photograph in your plant. Although the inspection manual provides authority to agents, the agency itself lacks statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529 (S.D. Iowa 1976). But these cases rely on the theory of implied consent or a minimal expectation of privacy. These cases do not hold that FDA has the right to photograph the interior of a device (or food) facility when the facility has a strict policy against photography and does not consent to the photography.
So, what should your stance be on the FDA’s request to photograph?
It’s important to ask yourself the following two questions:
- Do you have a policy against photography in your plant?
- If you do, is the policy strictly enforced?
If the answer to either question is no, then you may be at risk in in resisting the FDA’s request. By not having a policy, or by not strictly enforcing the policy, the FDA’s legal authority based on implied consent is strengthened.
Even if you answer yes to both, you still should weigh the risk of saying no to the FDA’s request. Assuming your plant does have a no-photography policy that is strictly enforced, you need to assess whether the photography is worth the fight. Resisting the request for photos may be worthwhile to protect potential disclosure of trade secrets and to prevent out-of-context photographs from being used adversely by FDA. The problem is that the harder you push against FDA, the more likely that it will seek more information and the more likely that it will seek enforcement action.
When considering what remedies and rights you can expect from a FDA inspection it’s important to consult with legal counsel. It’s better to be prepared, then left unsure when the FDA arrives!
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