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993014

Bristol-Myers Squibb Manufacturing Company Unlimited Company — FEI 2623458

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 18, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Humacao, PR (United States)

Facility

Other inspections at this facility

  • 1121802 (NAI Fri Feb 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1051117 (VAI Fri Apr 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 956226 (NAI Wed Dec 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866747 (VAI Thu Feb 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 768189 (NAI Thu Feb 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
154021 CFR 211.125(a)Strict control not exercised over labeling issued
200921 CFR 211.188Prepared for each batch, include complete information
430321 CFR 211.67(b)Written procedures fail to include