483
Abbey Color IncorporatedFDA 483 - Abbey Color Incorporated - January 29, 2020
Record Details
An FDA inspection of Abbey Color Incorporated in Philadelphia, PA, an API manufacturer of Fluorescein USP, revealed multiple significant Good Manufacturing Practice deficiencies. These included repeat observations regarding inadequate supplier qualification and deficient laboratory instrument calibration. Other findings involved incomplete deviation investigations, an insufficient stability program, deficient batch production records, and a lack of written equipment maintenance procedures.
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ID · 56618d85-3cec-4311-8bd5-a9b4314f1797