Biological E. Limited – FDA 483

This FDA Form 483 report for Biological E. Limited in Medchal-Malkajgiri District, India, details significant deficiencies in aseptic processing, quality control, and laboratory procedures. The inspection revealed issues including inadequate corrective actions for media fill failures, insufficient microbiological contamination prevention, and lack of proper oversight by the quality control unit. These observations indicate a high severity of non-compliance with cGMP regulations, particularly concerning sterile drug product manufacturing.