Warning letter
Ascension Orthopedics, Inc [ARCHIVED]: warning letter of Sep 16, 2010
FDA warning letter 117648 · Dallas District Office
Key facts
| Reference number | 117648 |
|---|---|
| Company | Ascension Orthopedics, Inc [ARCHIVED] |
| Subject | Medical Device Reporting(MDR) Regulation Misbranded |
| Issue date | Sep 16, 2010 |
| Posted date | Sep 16, 2010 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 806, 803, 803.17, 803.17(a)(1), 803.17(a)(2), 803.17(b)(1), 803.17(b)(2), 803.50(a)(1), 803.50(a)(2), 806.10(a)(1), 820 |
| Inspection city | Austin |
| Inspection ZIP | 78754 |
| Inspection start date | Mar 5, 2010 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: