FDA 483 - Sionc Pharmaceuticals Private Limited - November 15, 2024

An FDA inspection of Sionc Pharmaceuticals Private Limited in Visakhapatnam, India, an Active Pharmaceutical Ingredient and intermediate manufacturer, revealed critical deficiencies in equipment maintenance and qualification. The firm failed to ensure that production equipment, including gaskets and filtration systems, was adequately maintained to prevent contamination of API and intermediates. These issues present a significant risk of chemical, microbiological, and particulate contamination in the manufactured products.