Warning letter
Unipharma, LLC: warning letter of Nov 6, 2019
FDA warning letter 585388 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 585388 |
|---|---|
| Company | Unipharma, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 6, 2019 |
| Posted date | Dec 17, 2019 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 201.66, 201.128, 211.34, 211.192, 341, 341.20, 201.66(b)(2), 211.100(a), 211.166(a) |
| Inspection city | Tamarac |
| Inspection ZIP | 33321 |
| Inspection start date | Apr 22, 2019 |
| 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: