FDA 483 - Blaine Labs Inc - December 22, 2025

Blaine Labs Inc. received a Form 483 for widespread deficiencies across its quality system, including failures in quality control unit procedures, inadequate investigations, and lack of microbiological controls. The firm also failed to establish adequate laboratory controls, stability testing, process validation, and equipment qualification, leading to the release of drug products without proper assurance of identity, strength, quality, and purity. These issues indicate a systemic breakdown in ensuring product quality and patient safety.