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729731

Frantz Medical Development Ltd — FEI 1526605

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 14, 2011
Fiscal Year
2011
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))
  • 1066754 (NAI Mon Sep 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 622665 (NAI Wed Oct 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
310821 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
312821 CFR 820.90(a)Nonconforming product control
337221 CFR 820.198(d)Records of MDR Investigation
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures