1. Regulations
  2. title 21
  3. chapter I-i6
  4. part 600
  5. subpart C
  6. § 600.21

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-l; 42 U.S.C. 216, 262, 263, 263a, 264.

CITE AS: 21 CFR 600.21