FDA 483 - Allay Pharmaceuticals, LLC - May 15, 2020

Alley Pharmaceuticals, LLC received a Form 483 citing significant deficiencies across its quality system. Observations included failures in quality unit responsibilities, complaint handling, process validation, stability testing, laboratory controls, data integrity, raw material testing, investigation of discrepancies, and employee training. These issues indicate a systemic breakdown in ensuring drug product quality, identity, strength, and purity.