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675506

Gottfried Medical, Inc. — FEI 1526072

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 27, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Toledo, OH (United States)

Facility

Other inspections at this facility

  • 1229541 (VAI Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981652 (VAI Fri Jul 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918081 (OAI Tue Mar 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
312821 CFR 820.90(a)Nonconforming product control
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures