Warning letter
Par Health USA, LLC & Endo USA, Inc.: warning letter of Apr 15, 2026
FDA warning letter 722121 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 722121 |
|---|---|
| Company | Par Health USA, LLC & Endo USA, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 15, 2026 |
| Posted date | Apr 21, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 211.160(b), 211.42(c)(10) |
| Inspection city | Rochester |
| Inspection ZIP | 48307 |
| Inspection start date | Oct 6, 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: