Warning letter
Optikem International Inc.: warning letter of Jun 20, 2024
FDA warning letter 680264 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 680264 |
|---|---|
| Company | Optikem International Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jun 20, 2024 |
| Posted date | Jul 9, 2024 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.166, 211.194, 211.22(a), 211.22(b), 211.25(a), 211.42(c)(10), 211.100(a), 211.113(b), 211.160(b), 211.165(b) |
| Inspection city | Denver |
| Inspection ZIP | 80227 |
| Inspection start date | Jan 17, 2024 |
| 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: