FDA Inspection
CosmoFrance, Inc.CosmoFrance, Inc. – FDA Inspection, Apr 2, 2019
Record Details
This FDA Inspection record concerns CosmoFrance, Inc., with an inspection on April 2, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f48ecfc0-14f4-40f5-9bc8-c3b2fff5a70f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084958
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 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 |
| October 30, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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