FDA 2021 483s – Bioresearch Monitoring

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 312.609058127
FD-1572, protocol compliance8454119
Informed consent648
21 CFR 312.62(b)483060
Case history records- inadequate or inadequate483060
21 CFR 312.62(a)131117
Accountability records121116
Unused drug disposition (investigator)1#N/A1
21 CFR 50.27(a)937
Consent form not approved/signed/dated726
Copy of consent form not provided211
21 CFR 312.64(b)967
Safety reports967
21 CFR 312.668719
Initial and continuing review626
Unanticipated problems246
21 CFR 312.20(a)513
Failure to submit an IND513
21 CFR 58.130(a)423
Conduct: in accordance with protocol423
21 CFR 312.503716
General responsibilities of sponsors3414
21 CFR 50.20358
Consent not obtained, exceptions do not apply314
Comparison of 2021 Top 10 BIMO 483 categories with 2020 and 2019 data

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.

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