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

An FDA inspection conducted at Cosway Company, Inc., a contract manufacturer of Over-the-Counter (OTC) drugs and cosmetics located in Carson, CA, from July 9 to July 11, 2013, identified a significant observation regarding the firm's quality system. The primary issue cited was the deficiency in complaint records, specifically the lack of documented investigational findings and follow-up actions for several product complaints. The inspection revealed that the company failed to adequately document investigations for three specific complaints: red spots found in 'Moisturizer SPF-15' (Lot CC2H1), an incorrect SKU and product identifier on the outer shipper case label for 'Acne Cleanser' (Lot CC3B1), and orange spots present in 'Anti-Aging Moisturizer Broad Spectrum SPF-20' (Lots CC3E3 and CC3E4). These findings indicate a gap in the company's adherence to established quality control procedures for managing and resolving product quality issues. The FDA's observations, communicated through a Form FDA 483 to Bruce H. Farrell, Director of Quality Services, underscore the importance of robust complaint handling systems within the regulatory framework governing drug and cosmetic manufacturing. While not a final determination of compliance, the document mandates that Cosway Company, Inc. review these observations and implement necessary corrective actions to ensure comprehensive investigation and resolution of all reported product quality concerns, and to communicate these actions to the FDA for review.