The FDA’s assertion that it has the authority to take photographs during on-site inspections, as clarified in recently issued draft guidance, is coming under challenge by drug industry counsel.
The agency constitutes refusal to allow photographs as limiting an FDA investigator’s ability to perform an inspection — an offense, under the FDA Safety and Innovation Act (FDASIA), that could result in a company’s products being deemed adulterated.
But at least one pharma defense lawyer argues that because the agency’s assertion is made through guidance, “it’s just wrong.”
Not allowing photography by an FDA investigator may be considered a limitation if “such photographs are determined by the investigator(s) to be necessary to effectively conduct that particular inspection,” the draft guidance Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection, released earlier this month, states (DID, July 15).
(Drug Industry Daily; full story available here; paid subscription necessary)