FDA 483 - Cosway Company, Inc. - November 10, 2011

An FDA inspection of Cosway Company Inc., conducted from October 26 to November 10, 2011, identified a critical observation concerning the firm's quality control and investigation processes. The main issue was that written records for investigations into product batches failing to meet specifications did not consistently include complete conclusions or follow-up actions. Specifically, the firm encountered multiple instances where batches exhibited 'out of specification' results for specific gravity. Despite these deviations, Cosway Company Inc.'s Quality Unit released the products for distribution without conducting thorough investigations to resolve the underlying problems. Furthermore, the firm and the product developer failed to collaborate effectively to address these quality discrepancies, with product release seemingly based solely on the developer's approval. This indicates a deviation from Good Manufacturing Practices requiring robust quality systems and comprehensive investigation of product deviations. Cosway Company Inc. is expected to implement corrective actions to enhance its investigation procedures, ensure proper documentation, and improve collaboration with developers to address quality issues before product release.