Congress has granted to FDA the authority to inspect any establishment that manufacturers, processes, packs, or holds food, drugs, devices, tobacco products, or cosmetics for interstate distribution (subject to some limitations related to pharmacies). A company must allow an inspection if FDA has arrived to conduct it at a reasonable time, within reasonable limits and in a reasonable manner. A company violates the Food, Drug and Cosmetic Act if it does not permit an inspection that comports the requirements.  However, the company has the right to receive a written notice regarding the inspection, verify that the person conducting the inspection is an FDA employee and to have FDA explain any issues of concern that arise during the inspection.  In addition, companies can (and should) make corrections as soon as they are identified by FDA, even during the inspection, and have those corrections noted in the FDA file.

FDA can require a company to provide documents during the inspection, but not all documents – only those expressly authorized by statute.  The law explicitly permits record inspection in specific instances; yet, FDA has a long history of imaginatively asserting new power to inspect records beyond the clear statutory grants. If your facility is subject to FDA inspection, ETL consultants and affiliated attorneys can assist you in protecting their rights during the inspection.  Even if your facility has not been inspected by FDA, it is wise to have someone, like ETL with knowledge of what FDA will look for help prepare your facility for such an inspection.  ETL can show the way through a successful FDA inspection.