Warning letter
Alpha Medical Instruments, LLC: warning letter of Oct 7, 2014
FDA warning letter 441304 · Los Angeles District Office
Key facts
| Reference number | 441304 |
|---|---|
| Company | Alpha Medical Instruments, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 7, 2014 |
| Posted date | Oct 14, 2014 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Mission Viejo |
| Inspection ZIP | 92691 |
| Inspection start date | Aug 5, 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: