Company
ChinaBeijing Polycon Medical Engineering Ltd., Beijing, China – FDA Inspections
Inspection records and compliance data for Beijing Polycon Medical Engineering Ltd. in Beijing. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected February 01, 2018.
Company Profile
This profile covers Beijing Polycon Medical Engineering Ltd. based in Beijing, China.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected February 1, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 1, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1041573 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Beijing Polycon Medical Engineering Ltd.
FEI Number
3000239403
Address
1 Liang Jia Dian, Beijing, China
Country
China
ID: a2fbaaf4-608d-486d-95f6-3c02dd5a641d