FDA Inspection
Beijing Polycon Medical Engineering Ltd.Beijing Polycon Medical Engineering Ltd. – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns Beijing Polycon Medical Engineering Ltd., with an inspection on February 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f5943601-c991-4551-a93b-ae0008a06dca
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1041573
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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