FDA 483 - Ultra Seal Corporation - November 19, 2021

An FDA inspection of Ultra Seal Corporation, a pharmaceutical repackager in New Paltz, NY, revealed significant deficiencies in their quality control unit, equipment cleaning validation, and discrepancy investigations. The firm failed to ensure proper stability testing and relied on non-validated test methods from a contract laboratory to release numerous drug products. Additionally, critical equipment cleaning procedures lacked validation and defined steps, and the firm failed to take market action for an out-of-specification homeopathic drug product.