Title 21
PART 211 SUBPART J
Subpart J - Records and Reports
- 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
- 43 FR 45077, Sept. 29, 1978, unless otherwise noted.
21:4.0.1.1.11.10.1.1 | SECTION 211.180 | 211.180 General requirements. | |
21:4.0.1.1.11.10.1.2 | SECTION 211.182 | 211.182 Equipment cleaning and use log. | |
21:4.0.1.1.11.10.1.3 | SECTION 211.184 | 211.184 Component, drug product container, closure, and labeling records. | |
21:4.0.1.1.11.10.1.4 | SECTION 211.186 | 211.186 Master production and control records. | |
21:4.0.1.1.11.10.1.5 | SECTION 211.188 | 211.188 Batch production and control records. | |
21:4.0.1.1.11.10.1.6 | SECTION 211.192 | 211.192 Production record review. | |
21:4.0.1.1.11.10.1.7 | SECTION 211.194 | 211.194 Laboratory records. | |
21:4.0.1.1.11.10.1.8 | SECTION 211.196 | 211.196 Distribution records. | |
21:4.0.1.1.11.10.1.9 | SECTION 211.198 | 211.198 Complaint files. |