Warning letter
China Daheng Group Inc.: warning letter of Jan 15, 2014
FDA warning letter 411469 · Center for Devices and Radiological Health
Key facts
| Reference number | 411469 |
|---|---|
| Company | China Daheng Group Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 15, 2014 |
| Posted date | Feb 17, 2014 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 1002.13, 1003.20, 1003.21, 1003.30, 1004.1, 1004.2, 1004.6, 1010, 1010.2, 1040.10(h)(1)(iv), 1003.10(b) and 7 more |
| Inspection city | Beijing |
| Inspection start date | Jul 15, 2013 |
| 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: