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969055

Aspen SA Sterile Operations (Pty) Ltd. — FEI 3007490529

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 19, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Port Elizabeth (South Africa)

Facility

Other inspections at this facility

  • 1249416 (OAI Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074310 (VAI Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882533 (NAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 786162 (NAI Thu May 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
116221 CFR 211.28(a)Protective Apparel Not Worn
356121 CFR 211.56(b)Written sanitation procedures lacking
360321 CFR 211.160(b)Scientifically sound laboratory controls