| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |