The European Medicines Agency (EMA) has reportedly concluded its investigation of alleged non-compliance with good manufacturing practice (GMP) at Ranbaxy Laboratories’ facility in Toansa, India, and will reinstate the GMP certificate that was suspended in January 2014. While EMA’s assessment apparently revealed a number of GMP deficiencies, EU regulators have concluded that they did not place public health at risk. The EU inspection followed non-compliance findings by the U.S. Food and Drug Administration (FDA), which prohibited imports from the facility beginning in January 2014. Additional details about FDA’s action appear in Issue 71 of this Bulletin.
According to EMA, the European inspection showed that “appropriate corrective and preventive measures have been put in place by the manufacturer, [and] there was no evidence that any medicines on the EU market that have an active pharmaceutical ingredient manufactured in Toansa were of unacceptable quality or presented a risk to the health of patients taking them.” See EMA News Release, June 5, 2014.