Warning letter
Sovereign Pharmaceuticals, LLC: warning letter of Jan 29, 2013
FDA warning letter 303858 · Dallas District Office
Key facts
| Reference number | 303858 |
|---|---|
| Company | Sovereign Pharmaceuticals, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Jan 29, 2013 |
| Posted date | Jan 29, 2013 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 341.40, 341.74, 211.110(a), 341.78(c)(2), 341.72(d)(7), 341.74(d)(1)(iii), 341.74(d)(1)(v), 341.78(d), 341.80(d)(1), 211.192 |
| Inspection city | Fort Worth |
| Inspection ZIP | 76118 |
| Inspection start date | Jan 18, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: