FDA 483 - Specialty Minerals, Inc. - September 23, 2025

An FDA inspection of Specialty Minerals, Inc. in Adams, MA, an API manufacturer, revealed significant deficiencies in laboratory record-keeping and quality control procedures. The firm failed to maintain complete stability testing records for its API products and lacked written procedures for its quality control unit, particularly regarding deviation management. These issues indicate a moderate level of non-compliance with good manufacturing practices.