Company
ChinaCOLOPLAST (CHINA) LTD., Zhuhai, China – FDA Inspections
Inspection records and compliance data for COLOPLAST (CHINA) LTD. in Zhuhai. 2 FDA inspections on record, last inspected May 14, 2015.
Company Profile
This profile covers COLOPLAST (CHINA) LTD. based in Zhuhai, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected October 13, 2011. Last inspected May 14, 2015.
Most cited issue areas
- Approval, inadequate purchasing data1 inspection
- Lack of or inadequate process validation1 inspection
- Sampling plans1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 14, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 928724 |
| October 13, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 750679 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
COLOPLAST (CHINA) LTD.
FEI Number
3005945907
Address
No. 202, Bao Cheng Road, ZHUHAI FREE TRADE ZONE, Zhuhai, China
Country
China
ID: c9c1bcd4-d6a4-4401-afd2-26e508bad32f