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1115473

Pedicraft, Inc. — FEI 1043568

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 17, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Jacksonville, FL (United States)

Facility

Other inspections at this facility

  • 1276546 (VAI Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992413 (NAI Wed Oct 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878550 (VAI Fri Apr 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 731969 (NAI Tue Jun 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate