Code of Federal Regulations · Section

§ 600.21 — Time Of Inspection

21 C.F.R. § 600.21

View:

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 C.F.R. § 600.20 21 C.F.R. § 600.22

Authorizing Statute

Definitions; generally
21 U.S.C. § 321
Regulations
42 U.S.C. § 216