FDA Inspection
Shanghai Gaohui Rubber And Plastic CompanyShanghai Gaohui Rubber And Plastic Company – FDA Inspection, Mar 26, 2015
Record Details
This FDA Inspection record concerns Shanghai Gaohui Rubber And Plastic Company, with an inspection on March 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 26, 2015
- Product Type
- Devices
View Company Profile
ID · fc0e1776-010e-4e32-a6f8-03f027df1e48
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 923313
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.100(a)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 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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