FDA 483 - Ultra Seal Corporation - September 20, 2023

Ultra Seal Corporation, a pharmaceutical packager in New Paltz, NY, received a Form 483 with five observations highlighting significant deficiencies in their quality control unit, equipment cleaning and validation, manufacturing process controls, and storage conditions. Key issues include a lack of stability testing, unvalidated test methods, inadequate equipment cleaning procedures, unperformed equipment and packaging validations, and unmonitored warehouse temperatures. These findings indicate a systemic failure to adhere to cGMP requirements, with some issues being repeat observations.