Warning letter
Prime Enterprises, Inc [ARCHIVED]: warning letter of Jan 29, 2009
FDA warning letter 41938 · Florida District Office
Key facts
| Reference number | 41938 |
|---|---|
| Company | Prime Enterprises, Inc [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Deviations/Adulterated |
| Issue date | Jan 29, 2009 |
| Posted date | Jan 29, 2009 |
| Issuing office | Florida District Office |
| Product type | Drugs |
| CFR sections cited | 333.250, 211.103, 211.192, 310.545, 330.14, 333, 201.66(b)(2), 211.100(a), 211.165(f), 211.166(a), 211.186(b)(9), 310.545(a)(22)(iii) and 4 more |
| Inspection city | Hialeah |
| Inspection ZIP | 33014-6316 |
| Inspection start date | Jul 28, 2008 |
| 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: