FDA warns Mylan about cGMP violations at its Indian facilities

Published: 20-Aug-2015
Regulatory

Includes poor monitoring of staff and the use of gloves containing tears and pinholes


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.

There is a lack of assurance that you maintain your manufacturing environment in a state of control suitable for aseptic processing

In addition, the FDA found 'unidentified white particles on gloves exposed to critical areas inside the RABS'.

'There is a lack of assurance that you maintain your manufacturing environment in a state of control suitable for aseptic processing,' the FDA said in its warning letter.

According to the FDA, some of these violations were 'recurrent and long-standing' and Mylan's investigations 'inadequate' and 'raise questions about the ability of your current corporate quality system to achieve overall compliance with CGMP'.

Mylan CEO Heather Bresch said in a statement: 'Since Mylan acquired the Agila injectables businesses in December 2013 to create a leading global injectables platform, we have been taking extensive action to integrate the Agila business into Mylan's One Quality Standard, and to ensure our leading position as a high quality, reliable source of injectables for the long term.

'As part of this ongoing process, we have a deep and unwavering commitment to quality everywhere we operate. We have been and will continue to work diligently to address all of the FDA's observations and have made important progress.'

  • Companies:
  • US Food and Drug Administration (FDA)
  • Mylan Pharmaceuticals
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