FDA Inspection
Cotton High Tech S.L.( d/ba COHITECH)Cotton High Tech S.L.( d/ba COHITECH) – FDA Inspection, Mar 8, 2018
Record Details
This FDA Inspection record concerns Cotton High Tech S.L.( d/ba COHITECH), with an inspection on March 8, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- March 8, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a8048caa-e3ac-4b83-a502-b983c188f1db
Inspection Facts
- Inspection number
- 1044917
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Cotton High Tech S.L.( d/ba COHITECH)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 8, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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