Warning letter
Acme United Corporation: warning letter of Oct 10, 2025
FDA warning letter 712324 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 712324 |
|---|---|
| Company | Acme United Corporation |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 10, 2025 |
| Posted date | Oct 21, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.167(a), 211.63, 211.100(a), 211.113(b), 211.192 |
| Inspection city | Brooksville |
| Inspection ZIP | 34601 |
| Inspection start date | Mar 18, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: