FDA announced on 16 September 2013 that it was issuing an import alert banning drugs manufactured at Ranbaxy’s Mohali plant in India. The news follows inspections that FDA carried out in September and December 2012, during which the agency identified significant good manufacturing practice (GMP) procedure violations at the site, including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.

One problem identified during the FDA inspections is reported to be a black fibre that could have been a hair from an employee’s arm or tape fragments found embedded in a tablet.

The announcement is not good news for India-based Ranbaxy, who has had two other plants, Dewas and Paonta Sahib, on FDA import alert since 2008, affecting both drug imports and drug applications to the US. In May 2013, Ranbaxy also pleaded guilty to violations of the Food, Drug, and Cosmetic Act (FDCA) and making false statements, agreeing to pay US$500 million in civil and criminal fines to resolve the litigation [1].

FDA has also ordered that the Mohali facility be subject to certain terms of the consent decree, which Ranbaxy signed in January 2012 [2]. The decree contains provisions to ensure GMP compliance at certain Ranbaxy facilities, including the Dewas and Paonta Sahib plants, as well as provisions addressing data integrity issues at those two facilities. The decree demands that Ranbaxy bring in third-party auditors for the facilities and that Ranbaxy has had to relinquish some of its 180-day marketing exclusivities for pending generic drug applications.

Ranbaxy in a press statement said that it is hopeful of an early resolution to the situation and remains committed to addressing all the concerns of FDA. The company added that it ‘believes that it has made further improvements at its Mohali facility since the last inspection in 2012’.

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy pays US$500 million to resolve US litigation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 27]. Available from: www.gabionline.net/Generics/News/Ranbaxy-pays-US-500-million-to-resolve-US-litigation

2.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy consent decree with FDA submitted to court [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 27]. Available from: www.gabionline.net/Generics/News/Ranbaxy-consent-decree-with-FDA-submitted-to-court

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