Ashland Specialty Ingredients, G.P. – FDA 483, Aug 7, 2025

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.