Abbey Color Incorporated – FDA 483, May 9, 2025

Abbey Color Incorporated, an API manufacturer in Philadelphia, PA, received a Form 483 with ten observations highlighting significant deficiencies in their quality system. Key issues include a lack of process validation for Fluorescein USP API, inadequate equipment qualification and calibration, poor data integrity controls, and a non-independent quality unit. Several observations are repeats from previous inspections, indicating persistent non-compliance.