Warning letter
MicroAire Surgical Instruments, LLC: warning letter of Dec 29, 2014
FDA warning letter 440739 · Baltimore District Office
Key facts
| Reference number | 440739 |
|---|---|
| Company | MicroAire Surgical Instruments, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 29, 2014 |
| Posted date | May 19, 2015 |
| Issuing office | Baltimore District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17(a), 803.17(a)(1), 803.17(a)(3), 820, 803.50(a) |
| Inspection city | Charlottesville |
| Inspection ZIP | 22911 |
| Inspection start date | Aug 11, 2014 |
| 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: