Warning letter
Osteomed, LP: warning letter of Feb 11, 2004
FDA warning letter UCM146830 · Dallas District Office
Key facts
| Reference number | UCM146830 |
|---|---|
| Company | Osteomed, LP |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Feb 11, 2004 |
| Posted date | Feb 11, 2004 |
| Issuing office | Dallas District Office |
| Product type | Biologics |
| CFR sections cited | 803.3(bb)(1), 820, 803, 803.50, 803.18(b)(1)(i) |
| Country | 3 |
| Inspection city | Addison |
| Inspection ZIP | 75001-4314 |
| Inspection start date | Sep 9, 2003 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: