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1147009

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company — FEI 2650089

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 12, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Manati, PR (United States)

Facility

Other inspections at this facility

  • 1110480 (VAI Tue Nov 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079769 (OAI Wed Feb 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030016 (VAI Mon Sep 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986929 (NAI Wed May 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949087 (NAI Tue Nov 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
145121 CFR 211.113(b)Procedures for sterile drug products
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
360321 CFR 211.160(b)Scientifically sound laboratory controls
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
369621 CFR 820.100(b)Documentation
430521 CFR 211.68(b)Backup data not assured as exact and complete
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures