FDA Inspection
CosmoFrance, Inc.CosmoFrance, Inc. – FDA Inspection, Oct 30, 2014
Record Details
This FDA Inspection record concerns CosmoFrance, Inc., with an inspection on October 30, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CosmoFrance, Inc.
- Inspection Date
- October 30, 2014
- Product Type
- Devices
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ID · dd8d0f5b-8c3a-4245-b784-0a61f358d1c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 910062
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of CosmoFrance, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 2, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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