FDA 483 - QuestSpecialty Corporation - June 12, 2025

QuestSpecialty Corporation in Brenham, TX, an OTC manufacturer, received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of established procedures for training, deviation management, OOS investigations, stability testing, CAPA, supplier management, process validation, cleaning validation, and change control. Additionally, the firm failed to perform identity testing for incoming drug product components like ethanol and lacked specifications for methanol impurity.