FDA 483 - Mylan Laboratories Limited - January 09, 2023

An FDA inspection of Mylan Laboratories Limited (SFF) in Bangalore, Karnataka, revealed significant deficiencies in their testing laboratory operations. The firm failed to establish scientifically sound test procedures for Capillary Electrophoresis impurity methods, relying heavily on unoptimized manual integration. Additionally, laboratory records were found to be incomplete, as not all versions of generated electropherograms were included or reviewed.