The FDA has released the 2021 483 data. With my mind being mostly preoccupied with bioresearch monitoring inspection preparation, let’s look at that data, focusing on the top 10.
| CFR Reference in 2021 | # 483s 2021 | # 483s 2020 | # 483s 2019 |
| 21 CFR 312.60 | 90 | 58 | 127 |
| FD-1572, protocol compliance | 84 | 54 | 119 |
| Informed consent | 6 | 4 | 8 |
| 21 CFR 312.62(b) | 48 | 30 | 60 |
| Case history records- inadequate or inadequate | 48 | 30 | 60 |
| 21 CFR 312.62(a) | 13 | 11 | 17 |
| Accountability records | 12 | 11 | 16 |
| Unused drug disposition (investigator) | 1 | #N/A | 1 |
| 21 CFR 50.27(a) | 9 | 3 | 7 |
| Consent form not approved/signed/dated | 7 | 2 | 6 |
| Copy of consent form not provided | 2 | 1 | 1 |
| 21 CFR 312.64(b) | 9 | 6 | 7 |
| Safety reports | 9 | 6 | 7 |
| 21 CFR 312.66 | 8 | 7 | 19 |
| Initial and continuing review | 6 | 2 | 6 |
| Unanticipated problems | 2 | 4 | 6 |
| 21 CFR 312.20(a) | 5 | 1 | 3 |
| Failure to submit an IND | 5 | 1 | 3 |
| 21 CFR 58.130(a) | 4 | 2 | 3 |
| Conduct: in accordance with protocol | 4 | 2 | 3 |
| 21 CFR 312.50 | 3 | 7 | 16 |
| General responsibilities of sponsors | 3 | 4 | 14 |
| 21 CFR 50.20 | 3 | 5 | 8 |
| Consent not obtained, exceptions do not apply | 3 | 1 | 4 |
Based on comparison of number of inspections per year, I am not sure we can really say there was much COVID impact in the data. COVID may have influenced observations, but all it really seemed to do is excaerbate already existing problems,
Key lesson in the data? The GCPs are struggling at accountability of documentation and decision making.
Investigations of a Dog 