FDA Inspection
Transcendencias Comerciales S.L.Transcendencias Comerciales S.L. – FDA Inspection, Oct 18, 2016
Record Details
This FDA Inspection record concerns Transcendencias Comerciales S.L., with an inspection on October 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d1f53731-04d9-4cde-a0c2-95a9e1dac133
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991810
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Transcendencias Comerciales S.L.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2018 | Not classified | Office of Inspections and Investigations |
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