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709156

Innolatex Sdn. Bhd. — FEI 3003117682

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 20, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Port Klang (Malaysia)

Facility

Other inspections at this facility

  • 1215638 (VAI Thu Jul 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009128 (NAI Thu Mar 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752824 (NAI Thu Nov 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures
315921 CFR 820.184DHR content
53721 CFR 820.70(a)Production processes
54621 CFR 820.75(a)Lack of or inadequate process validation