| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1726 | 21 CFR 211.86 | Rotation of components/containers/closures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 4415 | 21 CFR 211.204 | Returned drug products with doubt cast as to safety et. al. |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |
| 8914 | 21 CFR 314.81(b)(2)(iv)(b) | Mfg and control changes not requiring a supplemental app. |