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1209932

Frantz Medical Development Ltd — FEI 1526605

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 27, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: 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))
  • 1066754 (NAI Mon Sep 24 2018 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
313021 CFR 820.100(a)Lack of or inadequate procedures
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
343421 CFR 820.75(c)Documentation - review in response to changes or deviations
369621 CFR 820.100(b)Documentation