FDA Inspection
Coloplast Hungary, KFT.Coloplast Hungary, KFT. – FDA Inspection, Sep 1, 2017
Record Details
This FDA Inspection record concerns Coloplast Hungary, KFT., with an inspection on September 1, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Coloplast Hungary, KFT.
- Inspection Date
- September 1, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 3968832f-7351-4f40-8f41-e8567a3a462a
Inspection Facts
- Inspection number
- 1024793
- 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 820.184DHR content
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Coloplast Hungary, KFT.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 25, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Coloplast Hungary, KFT.
- FDA Inspection 868322 - 2014-03-04
- FDA Inspection 607321 - 2009-06-25
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