Warning letter
Nidek Medical Products Inc [ARCHIVED]: warning letter of Jan 20, 2009
FDA warning letter 42638 · New Orleans District Office
Key facts
| Reference number | 42638 |
|---|---|
| Company | Nidek Medical Products Inc [ARCHIVED] |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 20, 2009 |
| Posted date | Jan 20, 2009 |
| Issuing office | New Orleans District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.11, 803.17, 803.50(a)(1), 803.50(a)(2), 807.81(a)(3)(i), 820, 803.50(b)(3), 807.81(a) |
| Inspection city | Birmingham |
| Inspection ZIP | 35217-1838 |
| Inspection start date | Sep 23, 2008 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: