DR. BROWN'S COMPANY – FDA 483, Apr 23, 2026

An FDA inspection of Dr. Brown's Company, a specification developer and U.S. distributor of AquaCool Water-Filled Teethers, revealed significant deficiencies in their quality system. The firm failed to adequately monitor product characteristics, validate sterilization and biocompatibility processes, establish proper purchasing controls with suppliers, and investigate product complaints. These issues indicate a lack of robust quality assurance for a Class II medical device.