FDA 483 - Mylan Laboratories Limited - April 12, 2018

An FDA inspection of Mylan Laboratories Limited in Sinnar, India, a drug product manufacturer, revealed significant deficiencies across its operations. Observations included failures in quality control unit procedures, inadequate investigation of production errors, and a lack of established written procedures for in-process controls. Additionally, the facility's building and employee amenities were found to be improperly maintained.