Warning letter
NIDEK Co., Ltd., Hamacho Plant: warning letter of Sep 24, 2013
FDA warning letter 410944 · Center for Devices and Radiological Health
Key facts
| Reference number | 410944 |
|---|---|
| Company | NIDEK Co., Ltd., Hamacho Plant |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Sep 24, 2013 |
| Posted date | Sep 24, 2013 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 820.40 |
| Inspection city | GAMAGORI |
| Inspection start date | May 20, 2013 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- ADC 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: