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1170399

Surgical Appliance Industries Inc — FEI 1511629

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 10, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Cincinnati, OH (United States)

Facility

Other inspections at this facility

  • 1220581 (NAI Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026101 (VAI Fri Sep 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802346 (VAI Tue Sep 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 724901 (VAI Wed Jun 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313021 CFR 820.100(a)Lack of or inadequate procedures
313221 CFR 820.120Lack of or inadequate procedures for labeling
315921 CFR 820.184DHR content
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures