COMMENT
Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. Enclosed are the “top fifteen” Observations. The Observations within the top fifteen usually do not change — although their frequency and ranking may vary. Please note that the frequencies of various Observations have markedly increased in FY 2012. Where a specific section is indicated, the Reference Number indicates the overall paragraph. You may wish to review this list with your own facility operations. Please review 21 CFR Part 211 for additional specifics.Â
| Ref No | Freq | Short Description |
|
21 Â CFR 211.22(d) |
169 |
Procedures not in writing, fully followed |
|
21 Â CFR 211.192 |
119 |
Investigations of discrepancies, failures |
|
21 Â CFR 211.100(a) |
116 |
Absence of Written Procedures |
|
21 Â CFR 211.160(b) |
115 |
Scientifically sound laboratory controls |
|
21 Â CFR 211.110(a) |
89 |
Control procedures to monitor and validate performance |
|
21 Â CFR 211.67(b) |
73 |
Written procedures not established/followed |
|
21 Â CFR 211.68(a) |
69 |
Calibration/Inspection/Checking  not done |
|
21 Â CFR 211.25(a) |
65 |
Training–operations, GMPs, written procedures |
|
21 Â CFR 211.67(a) |
65 |
Cleaning/Sanitizing/ Maintenance |
|
21 Â CFR 211.100(b) |
64 |
SOPs not followed/documented |
|
21 Â CFR 211.165(a) |
62 |
Testing and release for distribution |
|
21 Â CFR 211.188 |
56 |
Prepared for each batch, include complete information |
|
21 Â CFR 211.25(a) |
54 |
GMP Training Frequency |
|
21 Â CFR 211.63 |
54 |
Equipment Design, Size and Location |
|
21 Â CFR 211.113(b) |
47 |
Procedures for sterile drug products |
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