The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired.
21 CFR Part 600 · Biological Products: General
§ 600.21 Time of inspection
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 38 FR 32048 20 Nov 1973
- 48 FR 26314 7 Jun 1983
- 64 FR 56449 20 Oct 1999
- 84 FR 12508 2 Apr 2019