Warning letter
Unipack LLC: warning letter of Dec 19, 2025
FDA warning letter 716621 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 716621 |
|---|---|
| Company | Unipack LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 19, 2025 |
| Posted date | Dec 30, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.160(b), 211.192, 211.194(a) |
| Inspection city | South Plainfield |
| Inspection ZIP | 07080 |
| Inspection start date | Jun 11, 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: