FDA 483 - Mars Fishcare North America, Inc. - April 07, 2023

Mars Fishcare North America, Inc. in Chalfont, PA, a veterinary drug manufacturer, was cited for six observations during an FDA inspection. The inspection revealed significant deficiencies in laboratory controls, including inadequate OOS investigations, insufficient active ingredient testing, and unqualified reference standards. Additionally, issues were noted with equipment design, cleaning validation, and computer system audit trail reviews, indicating a broad lack of adherence to GMP regulations.