Food/Cosmetics: FDA inspections and Form 483 observations
81,678 firms with at least one Food/Cosmetics inspection. Most serious classification on file: 47,024 NAI, 30,709 VAI, 3,945 OAI.
The 25 observations cited most often (Foods program)
| Regulation | Observation | Times cited |
|---|---|---|
| 21 CFR 1.502(a) | Develop FSVP | 4,717 |
| 21 CFR 123.11(b) | Sanitation monitoring | 3,756 |
| 21 CFR 110.35(c) | Lack of effective pest exclusion | 3,540 |
| 21 CFR 123.6(b) | HACCP plan implementation | 2,767 |
| 21 CFR 110.20(b)(7) | Screening | 2,342 |
| 21 CFR 123.6(c)(1) | Food safety hazards | 2,014 |
| 21 CFR 110.20(b)(4) | Floors, walls and ceilings | 1,969 |
| 21 CFR 123.6(c)(2) | Critical control points | 1,942 |
| 21 CFR 123.6(c)(3) | Critical limits | 1,808 |
| 21 CFR 110.35(a) | Buildings/sanitary | 1,793 |
| 21 CFR 123.6(b) | No HACCP plan | 1,658 |
| 21 CFR 123.6(c)(4) | Monitoring - adequacy | 1,637 |
| 21 CFR 123.11(c) | Sanitation Records | 1,584 |
| 21 CFR 117.35(c) | Pest control | 1,542 |
| 21 CFR 123.6(c)(5) | Corrective action plan | 1,522 |
| 21 CFR 110.80(b)(2) | Manufacturing conditions | 1,504 |
| 21 CFR 123.12(a)(2) | Importer verification | 1,495 |
| 21 CFR 117.35(a) | Sanitary operations - Plant maintenance | 1,489 |
| 21 CFR 110.35(a) | Buildings/good repair | 1,457 |
| 21 CFR 110.20(a)(1) | Harborage areas | 1,434 |
| 21 CFR 117.10 | Personnel | 1,421 |
| 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls | 1,395 |
| 21 CFR 110.35(a) | Cleaning and sanitizing operations | 1,343 |
| 21 CFR 110.80(b)(7) | Equipment, containers, utensils | 1,302 |
| 21 CFR 110.80 | Reasonable precautions | 1,294 |
Frequencies of posted Form 483 citations, all fiscal years. They describe what investigators write most often, not any firm.
By state
- Alabama — 558
- Alaska — 356
- American Samoa — 6
- Arizona — 927
- Arkansas — 351
- California — 9,362
- Colorado — 1,064
- Connecticut — 425
- Delaware — 200
- District of Columbia — 93
- Florida — 3,697
- Georgia — 1,555
- Guam — 29
- Hawaii — 792
- Idaho — 575
- Illinois — 2,605
- Indiana — 975
- Iowa — 803
- Kansas — 738
- Kentucky — 831
- Louisiana — 1,031
- Maine — 493
- Maryland — 950
- Massachusetts — 1,296
- Michigan — 1,331
- Minnesota — 1,787
- Mississippi — 355
- Missouri — 1,277
- Montana — 549
- Nebraska — 400
- Nevada — 349
- New Hampshire — 253
- New Jersey — 2,709
- New Mexico — 328
- New York — 3,686
- North Carolina — 1,180
- North Dakota — 558
- Northern Mariana Islands — 16
- Ohio — 2,047
- Oklahoma — 587
- Oregon — 1,791
- Pennsylvania — 2,800
- Puerto Rico — 662
- Rhode Island — 213
- South Carolina — 529
- South Dakota — 385
- Tennessee — 1,170
- Texas — 4,166
- U.S. Virgin Islands — 46
- Utah — 586
- Vermont — 274
- Virginia — 1,110
- Washington — 2,204
- West Virginia — 219
- Wisconsin — 2,459
- Wyoming — 81