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

Cosway Company, Inc., a contract manufacturer of over-the-counter drugs and cosmetics, underwent an FDA inspection from July 9 to July 11, 2013. The inspection resulted in the issuance of an FDA Form 483, highlighting a significant observation regarding the firm's quality management system. The primary issue identified was that complaint records were deficient, specifically lacking documented investigational findings and follow-up for various product concerns. Examples included customer complaints about red spots in a moisturizer, an incorrect product identifier on an acne cleanser, and orange spots in an anti-aging moisturizer. This observation indicates a failure to adequately investigate and document product-related issues, which is essential for maintaining product quality and compliance with manufacturing standards. Cosway Company, Inc. is required to respond to the FDA 483 by outlining their planned corrective and preventive actions to address the identified deficiencies in their complaint handling system, demonstrating their commitment to regulatory compliance.