FDA 483_RESPONSE - Cosway Company, Inc. - February 24, 2023

Cosway Company, Inc. underwent an FDA inspection from February 16 to February 24, 2023, resulting in a Form 483 report highlighting significant compliance issues. The primary violations identified were inadequate laboratory controls and improper storage conditions for drug products.

Firstly, the inspection revealed that the laboratory equipment used for testing various over-the-counter drug products, such as Supergoop! Play SPF 30 Everyday Lotion, Dermalogica Protection 50 Sport SPF 50, and Murad Acne Control Clarifying Cream Cleanser, had not been qualified. This lack of qualification documentation for the equipment compromised the assurance of product identity, strength, quality, and purity. In response, Cosway committed to qualifying all relevant equipment according to established SOPs, completing this process by September 30, 2023. Additionally, retraining for R&D personnel was conducted to emphasize the importance of using qualified instruments.

Secondly, the company failed to investigate temperature excursions in its warehouses, where temperatures reached between 90°F and 100°F, potentially affecting product quality. The warehouses store both finished products and raw materials, which require specific temperature conditions. Cosway plans to revise its SOP for monitoring warehouse temperatures, upgrade temperature monitoring systems, and ensure appropriate storage conditions for raw materials. These corrective actions are expected to be completed by May 5, 2023.

Cosway's response indicates a commitment to addressing these issues and aligning with regulatory expectations to ensure product safety and compliance.