Warning letter
Epimed International, Inc.: warning letter of Sep 19, 2012
FDA warning letter 317898 · New York District Office
Key facts
| Reference number | 317898 |
|---|---|
| Company | Epimed International, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 19, 2012 |
| Posted date | Sep 19, 2012 |
| Issuing office | New York District Office |
| Product type | Devices |
| CFR sections cited | 820, 807.81(b) |
| Inspection city | Johnstown |
| Inspection ZIP | 12095 |
| Inspection start date | May 1, 2012 |
| 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: