21 CFR 600.21 - Time of inspection.

Regulations last checked for updates: Jun 01, 2024

Title 21 - Food and Drugs last revised: May 30, 2024

View all text of Subpart C [§ 600.20 - § 600.22]

§ 600.21 - Time of inspection.

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.

[38 FR 32048, Nov. 20, 1973, as amended at 48 FR 26314, June 7, 1983; 64 FR 56449, Oct. 20, 1999; 84 FR 12508, Apr. 2, 2019]

authority: 21 U.S.C. 321,351,352,353,355,356c,356e,360,360i,371,374,379k; 42 U.S.C. 216,262,263,263a,264

cite as: 21 CFR 600.21