Warning letter
Henan Kangdi Medical Devices Co. Ltd: warning letter of Dec 3, 2019
FDA warning letter 587699 · Center for Drug Evaluation and Research
Key facts
| Reference number | 587699 |
|---|---|
| Company | Henan Kangdi Medical Devices Co. Ltd |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved |
| Issue date | Dec 3, 2019 |
| Posted date | Dec 31, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.137(a), 201.128, 211.34, 330.1, 211.84(d)(1), 211.165(a) |
| Inspection city | Zhoukou |
| Inspection start date | Mar 4, 2019 |
| Letter on fda.gov | fda.gov |
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: