What are FDA investigators authorized to inspect?
FDA investigators are authorized to enter a drug manufacturer’s place of business to inspect the buildings, equipment, finished and unfinished materials, containers, and labeling. In the case of prescription drugs such as compressed medical gases, the inspection authority includes access to all records (including shipping and receiving records), but not including financial records. 5. QUESTION: What do FDA investigators routinely look for during an inspection? ANSWER: They look to see whether compressed medical gases are being manufactured according to FDA’s current good manufacturing practice (CGMP) regulations. FDA investigators will also look at labeling to determine compliance with FDA’s labeling regulations (21 CFR Part 201). 6. QUESTION: What are the CGMP regulations? ANSWER: Section 501(a)(2)(B) of the Act requires that the methods used in the manufacture, processing, packing, or holding and the facilities used must conform to current good manufacturing practice. The CGMP regula
