Devices: FDA inspections and Form 483 observations
17,223 firms with at least one Devices inspection. Most serious classification on file: 6,655 NAI, 8,712 VAI, 1,856 OAI.
The 25 observations cited most often (Devices program)
| Regulation | Observation | Times cited |
|---|---|---|
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 4,323 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 3,090 |
| 21 CFR 803.17 | Lack of Written MDR Procedures | 1,697 |
| 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures | 1,628 |
| 21 CFR 820.75(a) | Lack of or inadequate process validation | 1,449 |
| 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures | 1,380 |
| 21 CFR 820.100(b) | Documentation | 1,312 |
| 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures | 1,011 |
| 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures | 992 |
| 21 CFR 820.181 | DMR - not or inadequately maintained | 794 |
| 21 CFR 820.25(b) | Training - Lack of or inadequate procedures | 762 |
| 21 CFR 820.198(c) | Investigation of device failures | 732 |
| 21 CFR 820.30(a) | Design control - no procedures | 678 |
| 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures | 666 |
| 21 CFR 820.184 | Lack of or inadequate DHR procedures | 653 |
| 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ | 653 |
| 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures | 637 |
| 21 CFR 820.40 | Procedures not adequately established or maintained | 605 |
| 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures | 598 |
| 21 CFR 820.184 | DHR - not or inadequately maintained | 586 |
| 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate | 576 |
| 21 CFR 820.198(a) | Complaints | 561 |
| 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities | 559 |
| 21 CFR 820.184 | DHR content | 553 |
| 21 CFR 803.50(a)(2) | Individual Report of Malfunction | 546 |
Frequencies of posted Form 483 citations, all fiscal years. They describe what investigators write most often, not any firm.
By state
- Alabama — 129
- Alaska — 2
- Arizona — 244
- Arkansas — 43
- California — 2,138
- Colorado — 255
- Connecticut — 236
- Delaware — 16
- District of Columbia — 27
- Florida — 973
- Georgia — 368
- Hawaii — 12
- Idaho — 24
- Illinois — 579
- Indiana — 236
- Iowa — 78
- Kansas — 102
- Kentucky — 87
- Louisiana — 88
- Maine — 37
- Maryland — 201
- Massachusetts — 699
- Michigan — 306
- Minnesota — 508
- Mississippi — 54
- Missouri — 255
- Montana — 14
- Nebraska — 42
- Nevada — 78
- New Hampshire — 97
- New Jersey — 477
- New Mexico — 25
- New York — 741
- North Carolina — 445
- North Dakota — 8
- Ohio — 585
- Oklahoma — 63
- Oregon — 117
- Pennsylvania — 585
- Puerto Rico — 86
- Rhode Island — 53
- South Carolina — 126
- South Dakota — 33
- Tennessee — 326
- Texas — 784
- Utah — 151
- Vermont — 24
- Virginia — 215
- Washington — 242
- West Virginia — 33
- Wisconsin — 265
- Wyoming — 5