FDA 483 - Pascal Company Inc - August 21, 2025

An FDA inspection of Pascal Company Inc in Bellevue, WA, revealed significant deficiencies in manufacturing controls, laboratory practices, and data integrity. The firm failed to adequately validate manufacturing processes for topical fluoride gels, lacked proper specifications and investigations for out-of-specification results, and exhibited poor controls over computer systems used for testing. These observations indicate a lack of assurance regarding the identity, strength, purity, and quality of their drug products.