FDA Inspection
Tianjin New Bay Bioresearch Co., Ltd.Tianjin New Bay Bioresearch Co., Ltd. – FDA Inspection, Mar 6, 2014
Record Details
This FDA Inspection record concerns Tianjin New Bay Bioresearch Co., Ltd., with an inspection on March 6, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 6, 2014
- Product Type
- Devices
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ID · ed9a5f64-073b-4b10-bf17-259f58288fc0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 871892
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(g)Design validation - documentation
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