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

Cosway Company Inc, a manufacturer in Carson, CA, was cited for significant quality control deficiencies during an FDA inspection. The firm repeatedly released product batches despite out-of-specification results for specific gravity without conducting thorough investigations. This indicates a failure in their quality unit's oversight and investigation procedures, as well as a lack of collaboration with the product developer to resolve critical issues.