FDA 483 - Biocon Limited - January 24, 2020

Biocon Limited, an Active Pharmaceutical Ingredients Manufacturer in Bommasandra Post, Bangalore, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning validation, insufficient investigation of non-conformances, poorly qualified production equipment, and failures in Quality Control Unit responsibilities. The firm also demonstrated inadequate material handling, storage, and documentation practices.