The US FDA has warned Indian generics company Mylan about manufacturing concerns at three of its plants in India. In a warning letter, the FDA said it had found 'significant violations of current good manufacturing practice' during inspections in August and September last year and in February this year. The inspections relate to Mylan's Agila Specialty Formulation Facility, Sterile Product Division, and Onco Therapies Limited 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.
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