FDA Inspection
COLOPLAST (CHINA) LTD.COLOPLAST (CHINA) LTD. – FDA Inspection, Oct 13, 2011
Record Details
This FDA Inspection record concerns COLOPLAST (CHINA) LTD., with an inspection on October 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- COLOPLAST (CHINA) LTD.
- Inspection Date
- October 13, 2011
- Product Type
- Devices
View Company Profile
ID · ee3a4756-7065-4818-9a7e-a8a87f8c6f67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750679
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of COLOPLAST (CHINA) LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for COLOPLAST (CHINA) LTD.
- FDA Inspection 928724 - 2015-05-14
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