Warning letter
Sovereign Pharmaceuticals, LLC: warning letter of Oct 5, 2022
FDA warning letter 634233 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 634233 |
|---|---|
| Company | Sovereign Pharmaceuticals, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 5, 2022 |
| Posted date | Nov 1, 2022 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.100(a), 600.3(h)(6), 207, 207.17, 211.192, 211.34, 211.22(d) |
| Inspection city | Fort Worth |
| Inspection ZIP | 76118 |
| Inspection start date | Apr 13, 2022 |
| 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: