FDA 483 - Derma Care Research Labs LLC - August 08, 2025

Derma Care Research Labs LLC, an OTC drug products and cosmetics manufacturer in Daytona Beach, FL, was cited for significant deficiencies in its laboratory controls and data integrity practices. The inspection revealed failures in thoroughly investigating out-of-specification results, establishing scientifically sound test procedures, maintaining complete laboratory records, and controlling computer systems to prevent unauthorized data manipulation. These issues indicate a serious lack of control over product quality and data reliability.