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Talk to a SpecialistTalk to a SpecialistLive counts, trends and risk signals across FDA enforcement. Showing all available FDA records.
Pick a measure to see it quarter by quarter. Lighter bars mark the first quarter of each fiscal year (October to December), which dips every year before activity recovers.
Form 483s per 100 inspections fell to 24.5 in Q4 FY26, the lowest of these 8 quarters, against 35.1 in Q1 FY25.
Two views of FDA citations. Volume shows what gets written up most often in the selected period. Severity shows the provisions behind OAI outcomes, where regulatory action follows.
Drug CGMP provisions hold 4 of the top 5. The risk score adds twice the provision's OAI citations in the last 12 months and the number of firms cited. Where one firm was cited for it in several inspections over 5 years, it also adds three times those inspections and a weight for the worst outcome. Ranked from FDA inspection citations, updated Nov 14, 2026. Assess your CAPA and investigations
Citation frequency by subsystem and quarter. Select a quality system to switch views, or a cell to open that subsystem's citations for the quarter.
| Subsystem | Q1 FY26 | Q2 FY26 | Q3 FY26 | Q4 FY26 | Q1 FY27* | Total | Assessment |
|---|---|---|---|---|---|---|---|
| Document Management | 129 | 141 | 126 | 70 | 9 | 475 | Assess |
| Training Management | 74 | 87 | 97 | 56 | 8 | 322 | Assess |
| CAPA | 90 | 62 | 86 | 65 | 9 | 312 | Assess |
| Quality Risk Management | 91 | 73 | 67 | 38 | 2 | 271 | Assess |
| Complaint Management | 108 | 49 | 46 | 29 | 2 | 234 | Assess |
| Investigations | 43 | 44 | 51 | 22 | 1 | 161 | Assess |
| Computer System Validation | 28 | 17 | 29 | 13 | None | 87 | Assess |
| Change Control | 51 | 9 | 1 | None | None | 61 | Assess |
Document Management and Training Management are the two most cited Quality Unit subsystems across these quarters.
Firms cited for the same CFR provision in two or more inspections over 5 years. Repeat findings are what turn a Form 483 into a warning letter.
| Firm | Repeated Provision | Times Cited | Outcomes | First to Last | Severity |
|---|---|---|---|---|---|
| Mead Johnson & Company, LLC | 21 CFR 106.55(a)System of process controls to prevent adulteration | 7x | NAIOAIVAI | 2022 to 2026 | Critical 21 |
| New York Blood Center Enterprises | 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs | 9x | NAIVAI | 2023 to 2026 | Critical 18 |
| Ocho Rios-Miami, Inc. | 21 CFR 123.6(b)HACCP plan implementation | 6x | OAI | 2022 to 2026 | Critical 18 |
| Gate Gourmet, Inc. | 21 CFR 117.35(a)Sanitary operations - Plant maintenance | 6x | OAIVAI | 2023 to 2026 | Critical 18 |
| Baxter Healthcare Corporation | 21 CFR 211.22(d)Procedures not in writing, fully followed | 5x | OAIVAI | 2022 to 2026 | Critical 15 |
| American Airlines, Inc. | 21 CFR 1250.67Prevention of contamination | 7x | VAI | 2024 to 2025 | High 14 |
| American Airlines, Inc. | 21 CFR 1250.63Prevention of the spread of communicable diseases | 6x | VAI | 2024 to 2025 | High 12 |
| New York Blood Center Enterprises | 21 CFR 606.65(e)Following manufacturer's instructions | 6x | NAIVAI | 2023 to 2026 | High 12 |
Severity weighs repeats, recency and OAI outcomes: 15 and above is critical, 9 to 14 high, 4 to 8 elevated. Showing 8 of 3,146 repeat groups.