FDA 483 - Quest Products LLC - November 07, 2024

Quest Products LLC, a manufacturer of finished drug products (tablets) in Kent, WA, was cited with six observations during an FDA inspection from October 30 to November 7, 2024. The inspection revealed significant deficiencies in process validation, quality control procedures, equipment qualification, cleaning validation, and batch record accuracy for their CankerMelts orally disintegrating drug tablet. These issues indicate a lack of adequate controls to assure drug product identity, strength, purity, and quality.