Warning letter
Encore Medical, LP: warning letter of Jan 11, 2007
FDA warning letter UCM076239 · Dallas District Office
Key facts
| Reference number | UCM076239 |
|---|---|
| Company | Encore Medical, LP |
| Subject | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated |
| Issue date | Jan 11, 2007 |
| Posted date | Jan 11, 2007 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 820.1, 803, 803.17, 820, 803.50(a) |
| Country | 3 |
| Inspection city | Austin |
| Inspection ZIP | 78758-5445 |
| Inspection start date | Sep 20, 2006 |
| 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: