Warning letter
Kor-Chem, Inc.: warning letter of Sep 11, 2023
FDA warning letter 661280 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 661280 |
|---|---|
| Company | Kor-Chem, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 11, 2023 |
| Posted date | Sep 19, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 207, 207.29, 207.41, 211.22, 211.34, 211.67(b), 211.84(d)(1), 211.84(d)(2), 211.100(a), 211.160(b), 211.165(b), 211.166(a) and 1 more |
| Inspection city | Atlanta |
| Inspection ZIP | 30336 |
| Inspection start date | Apr 26, 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: