Bristol Myers Squibb - August 13, 2010
Issue Date
Aug 13, 2010
Region
Southeast
Category
Drug
$117.00
Address 1
Rd. 686 Km 2.3
Address 2
Bo. Tierras Nuevas
City
Manati
Zip/Postal Code
00674
Country
PR
Inspection Range
Jul 14, 2010 - Aug 13, 2010
Pages
2
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch of any of its components to meet any of its specifications whether or not the batch has been already distributed.
Specifically, your firm does not always identify, document and/or investigate discrepancies or atypical events that may impact the potency, quality, identity or purity of a material or product.
Investigator(s): Jose R. Lopez and Raquel Gonzalez RiveraSpecifically, your firm does not always identify, document and/or investigate discrepancies or atypical events that may impact the potency, quality, identity or purity of a material or product.