Shook Attorneys Explore Limits on Photography During FDA Inspections

Shook Partners Lindsey Heinz and Katie Gates Calderon, with Associate Hillary Nicholas, have authored an article for Law360 discussing regulations related to the use of photography during a U.S. Food and Drug Administration (FDA) inspection of a production facility.

“Despite the void of statutory authority, the FDA continues to instruct its inspectors to ‘not request permission from management to take photographs during an inspection’ and to instead simply begin taking photos and video,” the authors explain. “Should a company object to these tactics, inspectors are encouraged to ‘[a]dvise management the U.S. Courts have held that photographs may lawfully be taken as part of an inspection.’ However, the two cases the FDA cites in support of this assertion — Dow Chemical Co. v. U.S. and U.S. v. Acri Wholesale Grocery Co. — do not stand for the unequivocal proposition suggested by the FDA.”

Heinz, Gates Calderon and Nicholas advise companies to determine their approach to photography before inspections begin and explain the policy during the inspection if needed. “Companies who decide to enforce a ‘no-photo’ policy during an FDA inspection are certainly well within their legal rights, but should be prepared to be labeled as ‘uncooperative’ by the FDA,” they conclude. “To ease these tensions, preparation is key: Should a company determine it will not allow photography during an inspection, it is important that the company work closely with corporate and legal counsel to determine an approach that will protect the company’s rights while remaining cooperative with the FDA so as to not impede the inspection.”