# FDA 483 - Specialty Minerals, Inc. - August 22, 2019

Source: https://www.globalkeysolutions.net/records/483/specialty-minerals-inc/5f08eb79-c699-4ce3-9c4a-167309670e99

> FDA 483 for Specialty Minerals, Inc. on August 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Minerals, Inc.
- Inspection Date: 2019-08-22
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Specialty Minerals, Inc. in Adams, MA, an active pharmaceutical ingredient manufacturer, revealed significant deficiencies in laboratory control records, customer complaint handling, and complaint investigations. The firm failed to maintain complete data for laboratory tests, did not close customer complaints within established timeframes, and conducted inadequate investigations into product contamination issues.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7