Loading…
Live counts, trends, and risk intelligence across FDA enforcement
Per fiscal quarter · fixed 8-quarter history, not affected by the period filter above (each point is one quarter, so it won't sum to the window totals)
Geographic + product-type breakdown · current vs prior fiscal year
Citation frequency across the 6 systems · click any cell for subsystem detail
| Subsystem | FY25 Q4 | FY26 Q1 | FY26 Q2 | FY26 Q3 | FY26 Q4 | Total |
|---|---|---|---|---|---|---|
| Document Management | 194 | 129 | 131 | 102 | 23 | 579 |
| Training Management | 111 | 72 | 84 | 86 | 30 | 383 |
| Quality Risk Management | 131 | 90 | 73 | 61 | 9 | 364 |
| CAPA | 117 | 83 | 60 | 68 | 33 | 361 |
| Complaint Management | 114 | 101 | 47 | 38 | 13 | 313 |
| Investigations | 66 | 41 | 43 | 40 | 3 | 193 |
| Computer System Validation | 37 | 27 | 17 | 24 | 2 | 107 |
| Change Control | 52 | 45 | 9 | 1 | N/A | 107 |
Provisions cited most often across FDA inspections · ranked by repeat citations at the same firm and by OAI outcomes in the last 12 months
Central Admixture Pharmacy Services, Inc. was cited under 21 CFR 211.192 in 5 separate inspections in the last five years, most recently 2025-09-05. Inspection outcomes: OAI, VAI.
ART MX, LLC was cited under 21 CFR 1.502(a) in 5 separate inspections in the last five years, most recently 2026-07-15. Inspection outcomes: OAI, VAI.
J & H Imports Services Corp. was cited under 21 CFR 1.502(a) in 5 separate inspections in the last five years, most recently 2024-04-12. Inspection outcomes: OAI, VAI.
Nephron SC, LLC was cited under 21 CFR 211.113(b) in 5 separate inspections in the last five years, most recently 2025-08-22. Inspection outcomes: OAI, VAI.
21 CFR 211.22(d) was cited 37 times across 37 firms in inspections that closed as OAI in the last 12 months, most recently 2026-06-12.
21 CFR 211.100(a) was cited 36 times across 36 firms in inspections that closed as OAI in the last 12 months, most recently 2026-06-12.
21 CFR 211.160(b) was cited 30 times across 30 firms in inspections that closed as OAI in the last 12 months, most recently 2026-06-12.
21 CFR 211.67(b) was cited 21 times across 21 firms in inspections that closed as OAI in the last 12 months, most recently 2026-06-12.
21 CFR 211.166(a) was cited 18 times across 18 firms in inspections that closed as OAI in the last 12 months, most recently 2026-06-12.
21 CFR 211.68(b) was cited 17 times across 17 firms in inspections that closed as OAI in the last 12 months, most recently 2026-06-03.
Firms cited for the same CFR violation in 2+ inspections within 5 years · severity = repeats × max-outcome × recency
| # | Firm | CFR | Description | Repeats | Outcomes | First → Last | Severity |
|---|---|---|---|---|---|---|---|
| 1 | New York Blood Center Enterprises | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs | 9 | NAIVAI | 2023-10-27 → 2026-04-23 | 18 |
| 2 | Ocho Rios-Miami, Inc. | 21 CFR 123.6(b) | HACCP plan implementation | 6 | OAI | 2022-03-17 → 2026-02-24 | 18 |
| 3 | Gate Gourmet, Inc. | 21 CFR 117.35(a) | Sanitary operations - Plant maintenance | 6 | OAIVAI | 2023-04-17 → 2026-04-09 | 18 |
| 4 | ART MX, LLC | 21 CFR 1.502(a) | Develop FSVP | 5 | OAIVAI | 2021-09-30 → 2026-07-15 | 15 |
| 5 | Mead Johnson & Company, LLC | 21 CFR 106.55(a) | System of process controls to prevent adulteration | 5 | OAIVAI | 2022-07-06 → 2025-11-14 | 15 |
| 6 | American Airlines, Inc. | 21 CFR 1250.67 | Prevention of contamination | 7 | VAI | 2024-02-08 → 2025-12-12 | 14 |
| 7 | New York Blood Center Enterprises | 21 CFR 606.65(e) | Following manufacturer's instructions | 6 | NAIVAI | 2023-10-27 → 2026-01-12 | 12 |
| 8 | American Airlines, Inc. | 21 CFR 1250.63 | Prevention of the spread of communicable diseases | 6 | VAI | 2024-02-08 → 2025-12-12 | 12 |
| 9 | Perrigo Wisconsin, LLC | 21 CFR 106.55(a) | System of process controls to prevent adulteration | 4 | OAIVAI | 2022-04-14 → 2026-02-13 | 12 |
| 10 | Baxter Healthcare Corporation | 21 CFR 211.22(d) | Procedures not in writing, fully followed | 4 | OAIVAI | 2022-05-12 → 2025-11-25 | 12 |
| 11 | Ocho Rios-Miami, Inc. | 21 CFR 123.6(c)(1) | Food safety hazards | 4 | OAI | 2023-07-17 → 2026-02-24 | 12 |
| 12 | Ridley USA Inc. | 21 CFR 507.34(a)(1) | Preventive Controls | 4 | OAIVAI | 2022-02-24 → 2026-06-08 | 12 |
| 13 | Ocho Rios Atlanta Inc. | 21 CFR 1.502(a) | Develop FSVP | 4 | OAIVAI | 2021-09-17 → 2025-09-30 | 12 |
| 14 | Ocho Rios-Miami, Inc. | 21 CFR 123.8(a)(3) | Verification - record review - frequency | 4 | OAI | 2023-07-17 → 2026-02-24 | 12 |
| 15 | Amor Nino Foods Inc | 21 CFR 123.6(c)(3) | Critical limits | 4 | NAIOAI | 2023-01-24 → 2026-01-16 | 12 |
| 16 | Baxter Healthcare Corporation | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance | 4 | OAI | 2022-05-12 → 2025-09-29 | 12 |
| 17 | AB Seafood Trading Inc. | 21 CFR 123.6(c)(1) | Food safety hazards | 5 | VAI | 2022-03-03 → 2025-10-17 | 10 |
| 18 | Acme Smoked Fish Corp. | 21 CFR 123.11(b) | Sanitation monitoring | 5 | VAI | 2022-10-27 → 2026-02-11 | 10 |
| 19 | New York Blood Center Enterprises | 21 CFR 606.160(b) | Required records | 5 | VAI | 2023-10-27 → 2026-02-11 | 10 |
| 20 | A TO Z DISTRIBUTOR INC | 21 CFR 1.502(a) | Develop FSVP | 3 | OAIVAI | 2021-09-20 → 2025-09-17 | 9 |
Inspection ↔ Citations ↔ Form 483s · recent 5 OAI inspections
Most-cited CFR codes in window
Top 15 countries by total FDA enforcement actions · trailing 24 months