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1275470

PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. — FEI 3007539489

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 26, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Changzhou (China)

Facility

Other inspections at this facility

  • 992391 (NAI Thu Oct 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834494 (NAI Thu May 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures