# FDA 483 - Ashland Specialty Ingredients, G.P. - February 17, 2023

Source: https://www.globalkeysolutions.net/records/483/ashland-specialty-ingredients-gp/989c7c0b-87a1-49a7-bd2e-c2dda3363b3d

> FDA 483 for Ashland Specialty Ingredients, G.P. on February 17, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ashland Specialty Ingredients, G.P.
- Inspection Date: 2023-02-17
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Ashland Specialty Ingredients, G.P. in Bridgewater, NJ, revealed a significant quality system deficiency. The firm failed to revalidate a manufacturing process after implementing a new film inspection step for its GAFCHROMICTM EBT3 film, neglecting to document the evaluation or validation of this critical change. This indicates a breakdown in change control and process validation procedures.

## Related Documents

- [483 - 2025-08-07](https://www.globalkeysolutions.net/records/483/ashland-specialty-ingredients-gp/885f25a2-8dd7-4551-aaeb-47b56412c512)

## Related Officers

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

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

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