FDA 483 - Blaine Labs Inc - December 22, 2025

An FDA inspection of Blaine Labs Inc. in Santa Fe Springs, CA, a drug manufacturer, revealed widespread deficiencies across its quality, laboratory, production, facilities, and materials systems. The firm failed to follow established procedures, conduct thorough investigations, ensure data integrity, and validate critical processes and equipment. These issues indicate a significant lack of adherence to current Good Manufacturing Practices, posing risks to drug product quality and patient safety.