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1215638

Innolatex Sdn. Bhd. — FEI 3003117682

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Port Klang (Malaysia)

Facility

Other inspections at this facility

  • 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))
  • 709156 (OAI Thu Jan 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
330921 CFR 820.120(b)Examination for accuracy
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
54621 CFR 820.75(a)Lack of or inadequate process validation