FDA 483 - Cosway Company, Inc. - July 11, 2013

During an inspection conducted from July 9-11, 2013, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Cosway Company, Inc., a contract manufacturer of Over-The-Counter (OTC) drugs and cosmetics located in Carson, CA. The report, addressed to Director of Quality Services Bruce H. Farrell, details a significant observation related to the firm's quality system. The primary issue identified was that complaint records were deficient, specifically lacking documentation of investigational findings and follow-up actions. This systemic deficiency was highlighted by several examples. For instance, the company failed to document investigational findings for a December 2012 complaint concerning red spots in a Moisturizer SPF-15 product. Similarly, a March 2013 complaint regarding an incorrect SKU and product identifier on an Acne Cleanser’s outer shipping case lacked documented investigation. Furthermore, a June 2013 complaint about orange spots in an Anti-Aging Moisturizer Broad Spectrum SPF-20 also showed a lack of documented investigational findings. These observations indicate a failure to adequately investigate and document product quality issues, which is a critical component of a robust quality management system for drug and cosmetic manufacturers. Cosway Company, Inc. is expected to address these findings by implementing comprehensive corrective actions to ensure all product complaints are thoroughly investigated, documented, and followed up on, aligning with regulatory expectations for quality and safety.