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

> 18,949 drugs firms inspected by the FDA since 2009, and the observations its investigators cite most often.

## 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](/state/al.md) — 147
- [Alaska](/state/ak.md) — 5
- [Arizona](/state/az.md) — 201
- [Arkansas](/state/ar.md) — 87
- [California](/state/ca.md) — 1,482
- [Colorado](/state/co.md) — 236
- [Connecticut](/state/ct.md) — 143
- [Delaware](/state/de.md) — 34
- [District of Columbia](/state/dc.md) — 29
- [Florida](/state/fl.md) — 1,143
- [Georgia](/state/ga.md) — 325
- [Hawaii](/state/hi.md) — 17
- [Idaho](/state/id.md) — 55
- [Illinois](/state/il.md) — 445
- [Indiana](/state/in.md) — 199
- [Iowa](/state/ia.md) — 83
- [Kansas](/state/ks.md) — 142
- [Kentucky](/state/ky.md) — 169
- [Louisiana](/state/la.md) — 146
- [Maine](/state/me.md) — 30
- [Maryland](/state/md.md) — 279
- [Massachusetts](/state/ma.md) — 420
- [Michigan](/state/mi.md) — 259
- [Minnesota](/state/mn.md) — 215
- [Mississippi](/state/ms.md) — 85
- [Missouri](/state/mo.md) — 347
- [Montana](/state/mt.md) — 26
- [Nebraska](/state/ne.md) — 73
- [Nevada](/state/nv.md) — 106
- [New Hampshire](/state/nh.md) — 49
- [New Jersey](/state/nj.md) — 738
- [New Mexico](/state/nm.md) — 40
- [New York](/state/ny.md) — 659
- [North Carolina](/state/nc.md) — 400
- [North Dakota](/state/nd.md) — 18
- [Ohio](/state/oh.md) — 448
- [Oklahoma](/state/ok.md) — 110
- [Oregon](/state/or.md) — 117
- [Pennsylvania](/state/pa.md) — 612
- [Puerto Rico](/state/pr.md) — 156
- [Rhode Island](/state/ri.md) — 40
- [South Carolina](/state/sc.md) — 159
- [South Dakota](/state/sd.md) — 22
- [Tennessee](/state/tn.md) — 314
- [Texas](/state/tx.md) — 881
- [U.S. Virgin Islands](/state/vi.md) — 3
- [Utah](/state/ut.md) — 138
- [Vermont](/state/vt.md) — 19
- [Virginia](/state/va.md) — 191
- [Washington](/state/wa.md) — 267
- [West Virginia](/state/wv.md) — 43
- [Wisconsin](/state/wi.md) — 174
- [Wyoming](/state/wy.md) — 7

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