Warning letter
Extremity Medical, LLC: warning letter of Feb 24, 2012
FDA warning letter 255914 · New Jersey District Office
Key facts
| Reference number | 255914 |
|---|---|
| Company | Extremity Medical, LLC |
| Subject | Medical Device Reporting Regulation/Adulterated/Misbranded |
| Issue date | Feb 24, 2012 |
| Posted date | Feb 24, 2012 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 803.50(b), 803, 803.3, 803.17, 803.12(a), 803.50(a)(1), 803.50(a)(2), 807.81(a)(3)(i), 820, 806.10(a), 807.81(b) |
| Inspection city | Parsippany |
| Inspection ZIP | 07054 |
| Inspection start date | Sep 28, 2011 |
| 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: