FDA 483 - BDR Pharmaceuticals International Private Ltd. - November 20, 2025

BDR Pharmaceuticals International Private, Ltd. in Halol, India, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate procedures to prevent microbiological contamination, insufficient laboratory controls for personnel monitoring and sample integrity, and poor maintenance of equipment and facility design in aseptic processing areas. These issues collectively indicate a lack of control over the sterile manufacturing environment and processes.