FDA Inspection
Cotton High Tech S.L.( d/ba COHITECH)Cotton High Tech S.L.( d/ba COHITECH) – FDA Inspection, Feb 20, 2015
Record Details
This FDA Inspection record concerns Cotton High Tech S.L.( d/ba COHITECH), with an inspection on February 20, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 20, 2015
- Product Type
- Devices
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ID · 0135aded-0f54-4d84-8414-84b75a2b336d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917252
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cotton High Tech S.L.( d/ba COHITECH)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| August 8, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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