FDA 483 - Cosmax USA, Inc. - September 12, 2025

Cosmax USA, Corporation in Carteret, NJ, was inspected by the FDA from September 9-12, 2025, revealing a significant deficiency in their stability testing program. The firm failed to include photostability testing for OTC sunscreen drug products containing photolabile UV active ingredients. This omission is critical as it directly impacts the quality, safety, and effectiveness of sunscreens, potentially compromising SPF efficacy and consumer protection.