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1217706

Jiangsu Guangda Medical Material Group Co., Ltd. — FEI 3006847952

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 31, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Nantong (China)

Facility

Other inspections at this facility

  • 1081397 (NAI Wed Dec 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 926501 (VAI Fri Apr 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802595 (VAI Wed Sep 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
313021 CFR 820.100(a)Lack of or inadequate procedures
319221 CFR 820.30(g)Design validation - user needs and intended uses
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.