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1051117

Bristol-Myers Squibb Manufacturing Company Unlimited Company — FEI 2623458

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 27, 2018
Fiscal Year
2018
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))
  • 993014 (VAI Fri Nov 18 2016 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
200921 CFR 211.188Prepared for each batch, include complete information
241921 CFR 211.198(a)Complaint Handling Procedure