FDA Inspection
Optikem International, Inc.Optikem International, Inc. – FDA Inspection, Jul 11, 2022
Record Details
This FDA Inspection record concerns Optikem International, Inc., with an inspection on July 11, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Optikem International, Inc.
- Inspection Date
- July 11, 2022
- Product Type
- Devices
View Company Profile
ID · 9f73b9a7-79f4-4665-a528-35c3d6964ead
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1174263
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Optikem International, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2024 | Not classified | Denver District Office | Drug Quality Assurance |
| December 11, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 3, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 11, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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