Warning letter
Pharmagen Laboratories, Inc: warning letter of Oct 24, 2014
FDA warning letter 435786 · New England District Office
Key facts
| Reference number | 435786 |
|---|---|
| Company | Pharmagen Laboratories, Inc |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 24, 2014 |
| Posted date | Nov 3, 2014 |
| Issuing office | New England District Office |
| Product type | Drugs |
| CFR sections cited | 211.167(a), 211.28(a), 211.42(c)(10)(iv), 211.113(b) |
| Inspection city | Stamford |
| Inspection ZIP | 06905 |
| Inspection start date | Aug 5, 2013 |
| Letter on fda.gov | web.archive.org |
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: