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1148637

A.M. Surgical, Inc. — FEI 3001617730

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Smithtown, NY (United States)

Facility

Other inspections at this facility

  • 1220727 (NAI Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1058783 (VAI Fri Jul 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922550 (NAI Thu Apr 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 810194 (NAI Tue Dec 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 694932 (VAI Fri Oct 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
260221 CFR 820.30(d)Design output - review and approval
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
317521 CFR 820.186QSR
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
342721 CFR 820.50(a)(2)Supplier oversight
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements