Abbey Color IncorporatedMay 9, 2025

FDA 483 - Abbey Color Incorporated - May 09, 2025

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Record Details

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.

Company: Abbey Color Incorporated
Inspection Date: May 9, 2025
Product Type: Drugs
Office: Philadelphia District Office
People: Christina K. Theodorou (Consumer Safety Officer)
Anastasia M. Shields (Consumer Safety Officer )
Lu Chen (Investigator)

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ID · 4d6f4d6d-58a6-4878-9548-babe255e7f28