Warning letter
Cao Medical Equipment Co., Ltd.: warning letter of Nov 30, 2018
FDA warning letter 568152 · Center for Drug Evaluation and Research
Key facts
| Reference number | 568152 |
|---|---|
| Company | Cao Medical Equipment Co., Ltd. |
| Subject | CAO Medical Equipment Co., Ltd., CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 30, 2018 |
| Posted date | Dec 18, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.165(a), 211.100(a), 211.84(d)(1), 211.63 |
| Inspection city | Langfang |
| Inspection start date | Jul 16, 2018 |
| 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: