Warning letter
CPAPNEA Medical Supply: warning letter of Jan 22, 2020
FDA warning letter 592737 · Office of Medical Device and Radiological Health Operations Division 3 West
Key facts
| Reference number | 592737 |
|---|---|
| Company | CPAPNEA Medical Supply |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Jan 22, 2020 |
| Posted date | Feb 25, 2020 |
| Issuing office | Office of Medical Device and Radiological Health Operations Division 3 West |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3), 803, 803.3, 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b), 803.50(a), 820 |
| Inspection city | Phoenix |
| Inspection ZIP | 85020 |
| Inspection start date | Jul 18, 2019 |
| Letter on fda.gov | fda.gov |
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: