FDA 483 - DLC Laboratories, Inc - December 12, 2019

DLC Laboratories, Inc., a drug manufacturer in Paramount, CA, was inspected and cited for multiple significant deficiencies across its production, quality, facilities, laboratory, packaging, and materials systems. Key issues include inadequate batch records, lack of process validation, insufficient investigations into returned products and recalls, and deficient laboratory controls. These observations indicate a systemic failure to adhere to good manufacturing practices, posing a moderate to severe risk to product quality and patient safety.