Wyeth-Ayerst Cordarone I.V. process validation deficiencies cited in Oct. 27 FDA warning letter.
Executive Summary
WYETH-AYERST CORDARONE I.V. PROCESS VALIDATION DEFICIENCIES cited among other observations in an Oct. 27 warning letter sent by FDA to the company regarding an Aug. 10 through Sept. 28 reinspection of Wyeth's Marietta, Penn. manufacturing facility. Cordarone I.V. (amiodarone) was approved on Aug. 3 for life-threatening arrhythmias ("The Pink Sheet" Aug. 7, T&G-1).