Warning letter
Alpha Medical Instruments, LLC: warning letter of Jun 24, 2013
FDA warning letter 393025 · Los Angeles District Office
Key facts
| Reference number | 393025 |
|---|---|
| Company | Alpha Medical Instruments, LLC |
| Subject | Investigational Device Exemptions(IDE)/Premarket Approval Application (PMA) |
| Issue date | Jun 24, 2013 |
| Posted date | Jun 24, 2013 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 820, 807.81(b) |
| Inspection city | Mission Viejo |
| Inspection ZIP | 92691 |
| Inspection start date | Dec 19, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- NAI 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: