FDA Inspection
Coloplast Manufacturing France SASColoplast Manufacturing France SAS – FDA Inspection, Jun 14, 2017
Record Details
This FDA Inspection record concerns Coloplast Manufacturing France SAS, with an inspection on June 14, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 14, 2017
- Product Type
- Medical Devices & Rad Health
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ID · a7805298-868d-4993-a422-aa0c3710c40b
Inspection Facts
- Inspection number
- 1014887
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
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