FDA Inspection
Coloplast A/SColoplast A/S – FDA Inspection, Sep 1, 2017
Record Details
This FDA Inspection record concerns Coloplast A/S, with an inspection on September 1, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 916117ce-9b97-4861-a661-31b1e9648920
Inspection Facts
- Inspection number
- 1024792
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Coloplast A/S
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2018 | Not classified | Office of Inspections and Investigations | |
| March 12, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Coloplast A/S
- FDA Inspection 1085915 - 2018-04-13
- FDA Inspection 929019 - 2015-03-12
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