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682115

Amerisource Health Services LLC — FEI 3000209995

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 16, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Columbus, OH (United States)

Facility

Other inspections at this facility

  • 1172267 (NAI Fri May 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023170 (NAI Wed Aug 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015801 (VAI Thu Jun 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936288 (NAI Thu Jul 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 835119 (NAI Mon Jun 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
149821 CFR 211.122(b)Labeling and packaging improperly approved/released
202721 CFR 211.192Investigations of discrepancies, failures
430321 CFR 211.67(b)Written procedures fail to include