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FDA issues warning letters to Indian firms Posted 28/08/2015

The US Food and Drug Administration (FDA) is not letting up with its policy of being tough on foreign manufacturers. In its latest action the agency has issued warnings to Indian drugmakers Mylan and Mahendra Chemicals for good manufacturing practice (GMP) violations.

FDA highlighted problems at three of Mylan’s plants that it acquired in its US$1.75 billion deal for Indian sterile injectables producer Agila Specialties. The action follows inspections of the three sites in India (Agila Specialty Formulation Facility [SFF], Agila Sterile Product Division [SPD] and Mylan Onco Therapies Limited [OTL]) by the FDA as much as a year ago, in 2014 and February 2015.

In response Mylan CEO Ms Heather Bresch commented that ‘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’.

Although FDA knew that Mylan had only recently bought the plants when the inspections started in 2014, it stated that the warning letter the agency had already issued should have been an indication of problems that needed tending to. The agency acknowledged Mylan’s intent to fix the issues, but said until it does, it will not accept any applications for new or generic drugs from the three facilities.

Problems highlighted at the Mahendra Chemicals plant included failure to record activities at the time they are performed and destruction of original records. Specifically some employees had been using ‘rough notes’ to capture critical manufacturing data and then destroyed these original records after transcription into the batch production records. Additionally, FDA investigators found backdated batch production records dated 10–25 February 2014, which were signed by the Production Manager and Technical Director when the Technical Director was not in the facility during these dates.

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Source: US FDA, Mylan

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