Baxter Healthcare of Puerto Rico - September 9, 2010

$117.00
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.

Specifically, there is no assurance that the criteria used for the evaluation and disposition of 15% Clinisol Sulfite Free (Amino Acid) Injection 500 ml; lot #P244269; Expiration date 10/2010 that was impacted by a failure event (broken damper) in filling line were adequate.