# FDA 483 - Ashland Specialty Ingredients, G.P. - August 07, 2025

Source: https://www.keypedia.com/records/483/ashland-specialty-ingredients-gp/885f25a2-8dd7-4551-aaeb-47b56412c512

> FDA 483 for Ashland Specialty Ingredients, G.P. on August 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ashland Specialty Ingredients, G.P.
- Inspection Date: 2025-08-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Ashland Specialty Ingredients, G.P. in Bridgewater, NJ, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including overdue equipment calibration, inadequate corrective and preventive action procedures, insufficient risk analysis, and failures in both customer complaint handling and internal quality audit processes. These issues indicate a systemic breakdown in maintaining established quality management procedures.

## Related Documents

- [483 - 2023-02-17](https://www.keypedia.com/records/483/ashland-specialty-ingredients-gp/989c7c0b-87a1-49a7-bd2e-c2dda3363b3d)

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.keypedia.com/companies/ashland-specialty-ingredients-gp/44a5910c-ad11-428b-acb7-1817c1d3c339

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248