Warning letter
Omron (Dalian) Co., Ltd. Plant 1: warning letter of Feb 14, 2012
FDA warning letter 273116 · Center for Devices and Radiological Health
Key facts
| Reference number | 273116 |
|---|---|
| Company | Omron (Dalian) Co., Ltd. Plant 1 |
| Subject | CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated |
| Issue date | Feb 14, 2012 |
| Posted date | Feb 14, 2012 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820 |
| Inspection city | Dalian |
| Inspection start date | Oct 17, 2011 |
| 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: