Warning letter
Nidek, Inc.: warning letter of Aug 8, 2014
FDA warning letter 434750 · San Francisco District Office
Key facts
| Reference number | 434750 |
|---|---|
| Company | Nidek, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 8, 2014 |
| Posted date | Aug 8, 2014 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 806, 820, 806.10(a) |
| Country | 1 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
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: