Sandoz Pharma bulk process validation failures draw FDA warning letter Feb. 1.
Executive Summary
SANDOZ PHARMA PROCESS VALIDATION FAILURES DRAW FDA WARNING LETTER Feb. 1 stemming from agency inspections of the company's Basel, Switzerland facility from June 22-28 and Nov. 2-10. The Sandoz responses to the FDA-483 report dated July 5 and 7, Sept. 20 and Nov. 24 "lack sufficient detail, explanations, or documentation to adequately address all of the deviations during the June and November inspections," the warning letter states.