FDA Inspection
CefimecaCefimeca – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns Cefimeca, with an inspection on April 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 932a2d50-1a82-428a-b845-70daca9f791f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013990
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of Cefimeca
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
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