Warning letter
Encore Medical, L.P.: warning letter of Jun 25, 2008
FDA warning letter UCM1048225 · New Orleans District Office
Key facts
| Reference number | UCM1048225 |
|---|---|
| Company | Encore Medical, L.P. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jun 25, 2008 |
| Posted date | Jun 25, 2008 |
| Issuing office | New Orleans District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.50(a)(2), 803.50(b)(1), 803.52(f)(1), 820 |
| Country | 3 |
| Inspection city | Hixson |
| Inspection ZIP | 37343 |
| Inspection start date | Jan 8, 2008 |
| 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: