Biologics: FDA inspections and Form 483 observations
8,735 firms with at least one Biologics inspection. Most serious classification on file: 5,174 NAI, 3,267 VAI, 294 OAI.
The 25 observations cited most often (Biologics program)
| Regulation | Observation | Times cited |
|---|---|---|
| 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs | 1,032 |
| 21 CFR 606.100(c) | Thorough investigations | 340 |
| 21 CFR 606.160(a)(1) | Concurrent documentation | 245 |
| 21 CFR 606.160(b) | Required records | 245 |
| 21 CFR 606.171 | Biological product deviation report | 215 |
| 21 CFR 606.160(a)(1) | Person performing, test results, interpretation | 205 |
| 21 CFR 606.60(a) | Equipment observed, standardized, calibrated | 132 |
| 21 CFR 606.65(e) | Following manufacturer's instructions | 124 |
| 21 CFR 606.20(b) | Qualifications of responsible personnel | 97 |
| 21 CFR 606.160(a)(1) | Legibility and indelibility | 81 |
| 21 CFR 606.60(b) | Equipment calibration frequency | 79 |
| 21 CFR 606.100(c) | Record review prior to release | 77 |
| 21 CFR 606.40(a)(1) | Provide space for examination | 72 |
| 21 CFR 606.60(a) | Maintain and clean equipment | 65 |
| 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration | 60 |
| 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions | 59 |
| 21 CFR 606.170(a) | Adverse Reaction - Investigations | 49 |
| 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations | 49 |
| 21 CFR 640.3(a)(1) | Donor suitability procedures not followed | 48 |
| 21 CFR 600.14(c) | When to report | 44 |
| 21 CFR 640.4(f) | Arm preparation | 41 |
| 21 CFR 600.10(b) | Personnel capabilities | 41 |
| 21 CFR 630.40(a) | Notification | 39 |
| 21 CFR 606.40 | Clean & orderly | 38 |
| 21 CFR 606.60(a) | Provide proper equipment to meet requirements | 37 |
Frequencies of posted Form 483 citations, all fiscal years. They describe what investigators write most often, not any firm.
By state
- Alabama — 146
- Alaska — 11
- Arizona — 168
- Arkansas — 62
- California — 869
- Colorado — 164
- Connecticut — 73
- Delaware — 19
- District of Columbia — 25
- Florida — 652
- Georgia — 258
- Guam — 2
- Hawaii — 35
- Idaho — 46
- Illinois — 334
- Indiana — 164
- Iowa — 83
- Kansas — 90
- Kentucky — 99
- Louisiana — 151
- Maine — 32
- Maryland — 177
- Massachusetts — 204
- Michigan — 199
- Minnesota — 131
- Mississippi — 66
- Missouri — 176
- Montana — 33
- Nebraska — 55
- Nevada — 90
- New Hampshire — 24
- New Jersey — 187
- New Mexico — 40
- New York — 363
- North Carolina — 256
- North Dakota — 25
- Ohio — 286
- Oklahoma — 79
- Oregon — 88
- Pennsylvania — 379
- Puerto Rico — 86
- Rhode Island — 25
- South Carolina — 115
- South Dakota — 30
- Tennessee — 224
- Texas — 760
- U.S. Virgin Islands — 2
- Utah — 108
- Vermont — 14
- Virginia — 176
- Washington — 166
- West Virginia — 31
- Wisconsin — 150
- Wyoming — 13