In an apparent move to enforce biosimilar quality requirements, the FDA hit Biocon Biologics with multiple Forms 483 (PDF) following an inspection spree of the drugmaker’s manufacturing operations in two countries. The regulatory agency conducted three on-site inspections of Biocon Biologics’ production plants in two sites in Bengaluru, India, and one facility in Johor, Malaysia, from Aug. 11 through Aug. 30 this year, the company said. Inspectors cited 11 observations at each of the sites in India and six observations at the Malaysian plant. Source: Fierce Pharma 01/09/2022