FDA Inspection 632588 — Bristol Myers Squibb

Bristol Myers Squibb — FEI 1000527006

The FDA completed an inspection of Bristol Myers Squibb on November 25, 2009 in Princeton, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 25, 2009
Fiscal Year
2010
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Princeton, NJ (United States)

Additional Details

Sponsor, Contract Research Organization

Citations

IDCFRDescription
745321 CFR 312.56(b)Investigator non-compliance
748221 CFR 312.50General responsibilities of sponsors