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1066754

Frantz Medical Development Ltd — FEI 1526605

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 24, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Mentor, OH (United States)

Facility

Other inspections at this facility

  • 1234363 (VAI Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1209932 (VAI Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 729731 (NAI Tue Jun 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 622665 (NAI Wed Oct 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures