Photo Shop

With respect to factory inspections, section 704 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) generally allows that for the purposes of enforcing the FDCA, appropriate officials of the U.S. Food and Drug Administration (“FDA”), after presenting appropriate credentials and with written notice, may enter (at reasonable times) any place in which regulated products are manufactured, processed, packed, or held and to reasonably inspect such place. This section of the FDCA explicitly addresses FDA’s authority to conduct inspections: this inspection authority is well established in some areas (e.g., inspections of physical facilities), but remains questionable in others. In particular, the language of section 704 does not expressly state that FDA is authorized to take photographs during in-plant inspections. Despite the lack of specific authority, it is not uncommon for an inspector to attempt to utilize a camera during an inspection. As a consequence, any company developing or manufacturing regulated products should be prepared to address this specific issue.

Unbeknownst to most companies inspected by FDA, the agency trains its inspectors via its Investigations Operation Manual to take a camera into facility inspections and to use the device during the course of an investigation without asking the company’s permission. Specifically, with respect to in-plant photography, the most recent version of the Investigations Operation Manual provides:

Do not request permission from management to take photographs during an inspection. Take your camera into the firm and use it as necessary just as you use other inspectional equipment.

If management objects to taking photographs, explain that photos are an integral part of an inspection and present an accurate picture of plant conditions. Advise management the U.S. Courts have held that photographs may lawfully be taken as part of an inspection.