FDA 483 - DLC Laboratories, Inc - January 31, 2025

DLC Laboratories, Inc. in Paramount, CA, was inspected by the FDA from January 27-31, 2025, and received a Form 483. The inspection revealed a significant deficiency in the firm's quality system, specifically the failure to establish written procedures for production and process controls to address nitrosamine impurities in amine-containing drug products. This indicates a serious lapse in ensuring drug product quality and safety.