German regulators hit Ranbaxy with another warning letter
Another warning letter has landed in the hands of Ranbaxy execs, this time from German regulators charging the company with failing to comply with GMP standards.
The Indian drugmaker, which has faced a load of criticism and warnings from Western regulators, was hit again with a statement of non-compliance in GMP (good manufacturing practices), report number 24.30.12/06 (which can be found in the EudraGMDP non-compliance report database).
From its June 27 inspection, the National Competent Authority (NCA) known as Bezirksregierung Köln, said that it considers that Ranbaxy “does not comply with the Good manufacturing Practice requirements referred to” in the GMP directive from the European Commission.
In terms of the details, the regulator said that it revealed “unsatisfactory investigations into media trials failures,” deficiencies with Ranbaxy’s design and operation of its cleanrooms, as well as controls for the preparation and sterilization of its equipment and controls for its aseptic filling.
The NCA also took particular notice of Ranbaxy’s sterile products, which it said are non-compliant. And the regulator also said that the company’s new GMP certificate for its Dewas, India site does not include sterile products.
Past Troubles
Back in 2010, Ranbaxy first recalled antibiotics made at its Dewas site and a consent decree from the FDA in 2013 also called for GMP compliance at the site.
But at another of the company’s sites in Toansa, EMA regulators most recently reinstated the GMP certificate for the facility.
All of the problems come as Ranbaxy back in 2013 pled guilty to manufacturing adulterated drugs and agreed to pay $500m.
