483
Specialty Minerals, Inc.Specialty Minerals, Inc. – FDA 483, Sep 23, 2025
Record Details
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.
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ID · bd1b2b5d-3001-4d39-ab8b-4f771f991333
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