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1044815

MPS Medical, Inc. — FEI 3011183328

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 16, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Brea, CA (United States)

Facility

Other inspections at this facility

  • 1178708 (NAI Fri Aug 05 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141254 (NAI Wed Apr 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
369621 CFR 820.100(b)Documentation