FDA 483 - Alpha Aromatics - December 12, 2023

Alpha Aromatics, a non-sterile drug manufacturer in Pittsburgh, PA, received a Form 483 with seven observations highlighting significant deficiencies in the manufacturing and quality control of their 62% Alcohol Antiseptic Foaming Hand Sanitizer. The firm failed to perform essential release testing, process validation, raw material identity testing, and establish expiration dates based on stability data. Additionally, issues were noted with cleaning validation, data integrity, and the absence of critical written procedures for the quality control unit, indicating a broad lack of control over drug product quality.