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1209270

Advance Medical Designs, Inc. — FEI 1037885

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 30, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Marietta, GA (United States)

Facility

Other inspections at this facility

  • 1065878 (NAI Thu Jul 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998135 (NAI Thu Dec 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 862338 (NAI Wed Jan 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 668662 (NAI Wed Jun 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
310421 CFR 820.30(j)Design history file
333121 CFR 820.181DMR - not or inadequately maintained
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements