Baxter Healthcare of Puerto Rico - September 9, 2010

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.