Specialty Minerals, Inc.September 23, 2025

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

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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.

Company: Specialty Minerals, Inc.
Inspection Date: September 23, 2025
Product Type: Drugs
Office: New England District Office
Person: Samir C. Gala (Drug Investigator)

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ID · bd1b2b5d-3001-4d39-ab8b-4f771f991333