FDA Inspection
Changshu Beyond Medical Device Co., Ltd.Changshu Beyond Medical Device Co., Ltd. – FDA Inspection, Jan 21, 2016
Record Details
This FDA Inspection record concerns Changshu Beyond Medical Device Co., Ltd., with an inspection on January 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 21, 2016
- Product Type
- Devices
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ID · c12d5c44-91a7-4318-a576-893ffe85fc62
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 958637
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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