Warning letter
Optikem International, Inc.: warning letter of Aug 13, 2024
FDA warning letter 683606 · Center for Devices and Radiological Health
Key facts
| Reference number | 683606 |
|---|---|
| Company | Optikem International, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 13, 2024 |
| Posted date | Sep 10, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 830.300(a), 801, 801.3, 830, 830.3, 807.81(b), 801.40(a)(1), 801.40(a)(2), 807.81(a)(3)(i), 801.20(a), 820 |
| Inspection city | Denver |
| Inspection ZIP | 80227 |
| Inspection start date | Feb 26, 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: