Warning letter
Handock Cosmetics Co., Ltd.: warning letter of Oct 4, 2023
FDA warning letter 658737 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 658737 |
|---|---|
| Company | Handock Cosmetics Co., Ltd. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register/Unapproved New Drug |
| Issue date | Oct 4, 2023 |
| Posted date | Oct 17, 2023 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 201.128, 207.29, 207.41, 211.22, 211.34, 211.63, 330, 211.84(d)(1), 211.84(d)(2), 207.57(b) |
| Inspection city | Namdong District |
| Inspection start date | Mar 20, 2023 |
| Letter on fda.gov | fda.gov |
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: