FDA 483 - Sionc Pharmaceuticals Private Limited - November 15, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 31ff0711-bde1-4998-b94e-95043ab65cd3