FDA 483 - Steriscience Specialties Private Limited - September 01, 2015

Mylan Laboratories Limited, a sterile drug manufacturer in Bangalore, India, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate equipment cleaning and disinfectant qualification, deficiencies in aseptic processing environmental monitoring, incomplete batch production records, and a lack of written procedures for the quality control unit. Additionally, the firm failed to establish proper procedures to prevent objectionable microorganisms in sterile areas and did not follow established stability testing protocols.