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

> 8,735 biologics firms inspected by the FDA since 2009, and the observations its investigators cite most often.

## 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](/state/al.md) — 146
- [Alaska](/state/ak.md) — 11
- [Arizona](/state/az.md) — 168
- [Arkansas](/state/ar.md) — 62
- [California](/state/ca.md) — 869
- [Colorado](/state/co.md) — 164
- [Connecticut](/state/ct.md) — 73
- [Delaware](/state/de.md) — 19
- [District of Columbia](/state/dc.md) — 25
- [Florida](/state/fl.md) — 652
- [Georgia](/state/ga.md) — 258
- [Guam](/state/gu.md) — 2
- [Hawaii](/state/hi.md) — 35
- [Idaho](/state/id.md) — 46
- [Illinois](/state/il.md) — 334
- [Indiana](/state/in.md) — 164
- [Iowa](/state/ia.md) — 83
- [Kansas](/state/ks.md) — 90
- [Kentucky](/state/ky.md) — 99
- [Louisiana](/state/la.md) — 151
- [Maine](/state/me.md) — 32
- [Maryland](/state/md.md) — 177
- [Massachusetts](/state/ma.md) — 204
- [Michigan](/state/mi.md) — 199
- [Minnesota](/state/mn.md) — 131
- [Mississippi](/state/ms.md) — 66
- [Missouri](/state/mo.md) — 176
- [Montana](/state/mt.md) — 33
- [Nebraska](/state/ne.md) — 55
- [Nevada](/state/nv.md) — 90
- [New Hampshire](/state/nh.md) — 24
- [New Jersey](/state/nj.md) — 187
- [New Mexico](/state/nm.md) — 40
- [New York](/state/ny.md) — 363
- [North Carolina](/state/nc.md) — 256
- [North Dakota](/state/nd.md) — 25
- [Ohio](/state/oh.md) — 286
- [Oklahoma](/state/ok.md) — 79
- [Oregon](/state/or.md) — 88
- [Pennsylvania](/state/pa.md) — 379
- [Puerto Rico](/state/pr.md) — 86
- [Rhode Island](/state/ri.md) — 25
- [South Carolina](/state/sc.md) — 115
- [South Dakota](/state/sd.md) — 30
- [Tennessee](/state/tn.md) — 224
- [Texas](/state/tx.md) — 760
- [U.S. Virgin Islands](/state/vi.md) — 2
- [Utah](/state/ut.md) — 108
- [Vermont](/state/vt.md) — 14
- [Virginia](/state/va.md) — 176
- [Washington](/state/wa.md) — 166
- [West Virginia](/state/wv.md) — 31
- [Wisconsin](/state/wi.md) — 150
- [Wyoming](/state/wy.md) — 13

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