COPLEY/FDA INVESTIGATION OF ALBUTEROL CONTAMINATION
Executive Summary
COPLEY/FDA INVESTIGATION OF ALBUTEROL CONTAMINATION is focusing on the packaging process for the 0.5% albuterol solution for inhalation. The post-recall review of the problem was facilitated because of the presence of FDA investigators at the time the contamination was initially discovered. FDA inspectors were at Copley's facilities conducting an unrelated, general GMP compliance inspection, checking the validation of three products and doing a preapproval clearance for five other products.