Warning letter
Apnea Sciences Inc: warning letter of May 9, 2013
FDA warning letter 392712 · Los Angeles District Office
Key facts
| Reference number | 392712 |
|---|---|
| Company | Apnea Sciences Inc |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | May 9, 2013 |
| Posted date | May 9, 2013 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 801.109, 803.17, 807.97, 807.81(a)(3)(ii), 820, 820.40, 807.81(b) |
| Inspection city | Henderson |
| Inspection ZIP | 89052 |
| Inspection start date | Nov 27, 2012 |
| 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: