# FDA inspections of devices firms — the most cited Form 483 observations

> 17,223 devices firms inspected by the FDA since 2009, and the observations its investigators cite most often.

## 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](/state/al.md) — 129
- [Alaska](/state/ak.md) — 2
- [Arizona](/state/az.md) — 244
- [Arkansas](/state/ar.md) — 43
- [California](/state/ca.md) — 2,138
- [Colorado](/state/co.md) — 255
- [Connecticut](/state/ct.md) — 236
- [Delaware](/state/de.md) — 16
- [District of Columbia](/state/dc.md) — 27
- [Florida](/state/fl.md) — 973
- [Georgia](/state/ga.md) — 368
- [Hawaii](/state/hi.md) — 12
- [Idaho](/state/id.md) — 24
- [Illinois](/state/il.md) — 579
- [Indiana](/state/in.md) — 236
- [Iowa](/state/ia.md) — 78
- [Kansas](/state/ks.md) — 102
- [Kentucky](/state/ky.md) — 87
- [Louisiana](/state/la.md) — 88
- [Maine](/state/me.md) — 37
- [Maryland](/state/md.md) — 201
- [Massachusetts](/state/ma.md) — 699
- [Michigan](/state/mi.md) — 306
- [Minnesota](/state/mn.md) — 508
- [Mississippi](/state/ms.md) — 54
- [Missouri](/state/mo.md) — 255
- [Montana](/state/mt.md) — 14
- [Nebraska](/state/ne.md) — 42
- [Nevada](/state/nv.md) — 78
- [New Hampshire](/state/nh.md) — 97
- [New Jersey](/state/nj.md) — 477
- [New Mexico](/state/nm.md) — 25
- [New York](/state/ny.md) — 741
- [North Carolina](/state/nc.md) — 445
- [North Dakota](/state/nd.md) — 8
- [Ohio](/state/oh.md) — 585
- [Oklahoma](/state/ok.md) — 63
- [Oregon](/state/or.md) — 117
- [Pennsylvania](/state/pa.md) — 585
- [Puerto Rico](/state/pr.md) — 86
- [Rhode Island](/state/ri.md) — 53
- [South Carolina](/state/sc.md) — 126
- [South Dakota](/state/sd.md) — 33
- [Tennessee](/state/tn.md) — 326
- [Texas](/state/tx.md) — 784
- [Utah](/state/ut.md) — 151
- [Vermont](/state/vt.md) — 24
- [Virginia](/state/va.md) — 215
- [Washington](/state/wa.md) — 242
- [West Virginia](/state/wv.md) — 33
- [Wisconsin](/state/wi.md) — 265
- [Wyoming](/state/wy.md) — 5

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Página: https://fda-inspection-records.pages.dev/product/devices/
Fonte: https://datadashboard.fda.gov/oii/cd/inspections.htm
Recolha: 2026-09-30