21 CFR Part 600 Subpart C: Establishment Inspections Overview

“This regulation outlines FDA requirements for inspecting establishments applying for biologics licenses. Key points include:

1. Inspectors: Inspections are conducted by FDA officers with specialized knowledge of manufacturing and control processes. Alternatively, authorized officers, agents, or employees of the Department of Health and Human Services may also conduct inspections.
2. Authority: The responsibility for inspections falls under the Commissioner of Food and Drugs, with authorization from the Secretary of Health and Human Services.
3. Inspection Timing: Inspections occur after the company begins producing the full product for which the biologics license is sought, not during the application process.”

Source:https://www.ecfr.gov/pdfs/412c80ef-b08b-4534-8f67-0b3944bde1db.pdf##~https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600/subpart-C

Region: United States of America