FDA warns Mylan about cGMP violations at its Indian facilities

The US FDA has warned Mylan about manufacturing concerns at three of its plants in India.

In a warning letter to the generic drug manufacturer, the FDA said it had found ‘significant violations of current good manufacturing practice’ during inspections at the plants in August and September last year and in February this year.

The inspections relate to Mylan’s Agila Specialty Formulation Facility (SFF), Sterile Product Division (SPD), and Onco Therapies Limited (OTL) sites in Bangalore.

Some of the violations cited were failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products, such as the use of gloves with tears and pinholes, as well as deficiencies in environmental monitoring and poor monitoring of staff……..http://www.manufacturingchemist.com/news/article_page/FDA_warns_Mylan_about_cGMP_violations_at_its_Indian_facilities/111318/cn48579?dm_i=8EU,3MBVR,9ETTTY,D0ENC,1

Recently the Food and Drug Administration (FDA) began ramping up inspections of offshore manufacturing facilities and the results are shocking. Although cGMP violations have been found worldwide, experts are…