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

Source: https://www.keypedia.com/records/483/specialty-minerals-inc/bd1b2b5d-3001-4d39-ab8b-4f771f991333

> FDA 483 for Specialty Minerals, Inc. on September 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Minerals, Inc.
- Inspection Date: 2025-09-23
- Product Type: drugs
- Office Name: New England District Office
- Summary: 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.

## Related Documents

- [483 - 2019-08-22](https://www.keypedia.com/records/483/specialty-minerals-inc/5f08eb79-c699-4ce3-9c4a-167309670e99)

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

Company: https://www.keypedia.com/companies/specialty-minerals-inc/fa1116ce-bf42-40c1-b849-1d18b36fdd72

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144