FDA 483 - Mylan Laboratories Limited - February 28, 2020

Mylan Laboratories Limited, Speciality Formulation Facility in Bangalore, India, was cited for significant deficiencies during an FDA inspection of its sterile drug manufacturing. The observations highlight inadequate laboratory controls, including unvalidated test methods and insufficient system suitability, as well as failures in out-of-specification investigations and quality control unit responsibilities. Additionally, issues were noted with process control procedures related to critical hold times and the scientific basis for environmental monitoring in aseptic areas.