Drugs: FDA inspections and Form 483 observations
18,949 firms with at least one Drugs inspection. Most serious classification on file: 7,396 NAI, 9,164 VAI, 2,389 OAI.
The 25 observations cited most often (Drugs program)
| Regulation | Observation | Times cited |
|---|---|---|
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 2,399 |
| 21 CFR 211.192 | Investigations of discrepancies, failures | 1,535 |
| 21 CFR 211.160(b) | Scientifically sound laboratory controls | 1,444 |
| 21 CFR 211.100(a) | Absence of Written Procedures | 1,419 |
| 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance | 940 |
| 21 CFR 211.67(b) | Written procedures not established/followed | 874 |
| 21 CFR 211.165(a) | Testing and release for distribution | 849 |
| 21 CFR 211.110(a) | Control procedures to monitor and validate performance | 751 |
| 21 CFR 211.166(a) | Lack of written stability program | 704 |
| 21 CFR 211.63 | Equipment Design, Size and Location | 697 |
| 21 CFR 211.68(a) | Calibration/Inspection/Checking not done | 693 |
| 21 CFR 211.113(b) | Procedures for sterile drug products | 678 |
| 21 CFR 211.100(b) | SOPs not followed / documented | 632 |
| 21 CFR 211.25(a) | Training--operations, GMPs, written procedures | 628 |
| 21 CFR 211.188 | Prepared for each batch, include complete information | 583 |
| 21 CFR 211.68(b) | Computer control of master formula records | 575 |
| 21 CFR 211.22(a) | Lack of quality control unit | 473 |
| 21 CFR 211.198(a) | Complaint Handling Procedure | 451 |
| 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System | 451 |
| 21 CFR 211.84(d)(2) | Reports of Analysis (Components) | 432 |
| 21 CFR 211.180(e)(2) | Items to cover on annual reviews | 414 |
| 21 CFR 211.165(e) | Test methods | 400 |
| 21 CFR 211.25(a) | Training , Education , Experience overall | 398 |
| 21 CFR 211.192 | Written record of investigation incomplete | 384 |
| 21 CFR 211.113(b) | Validation lacking for sterile drug products | 381 |
Frequencies of posted Form 483 citations, all fiscal years. They describe what investigators write most often, not any firm.
By state
- Alabama — 147
- Alaska — 5
- Arizona — 201
- Arkansas — 87
- California — 1,482
- Colorado — 236
- Connecticut — 143
- Delaware — 34
- District of Columbia — 29
- Florida — 1,143
- Georgia — 325
- Hawaii — 17
- Idaho — 55
- Illinois — 445
- Indiana — 199
- Iowa — 83
- Kansas — 142
- Kentucky — 169
- Louisiana — 146
- Maine — 30
- Maryland — 279
- Massachusetts — 420
- Michigan — 259
- Minnesota — 215
- Mississippi — 85
- Missouri — 347
- Montana — 26
- Nebraska — 73
- Nevada — 106
- New Hampshire — 49
- New Jersey — 738
- New Mexico — 40
- New York — 659
- North Carolina — 400
- North Dakota — 18
- Ohio — 448
- Oklahoma — 110
- Oregon — 117
- Pennsylvania — 612
- Puerto Rico — 156
- Rhode Island — 40
- South Carolina — 159
- South Dakota — 22
- Tennessee — 314
- Texas — 881
- U.S. Virgin Islands — 3
- Utah — 138
- Vermont — 19
- Virginia — 191
- Washington — 267
- West Virginia — 43
- Wisconsin — 174
- Wyoming — 7