Bristol Myers Squibb - August 13, 2010

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.