Ranbaxy received warning letter from German Regulators
Recently Ranbaxy has faced a lot of criticism and received warning letters from western regulators such as USFDA regarding non-compliance with GMP (Good Manufacturing Practices). Ranbaxy has received warning letter from another regulator i.e German regulator for not complying with GMP.
According to The National Competent Authority known as Bezirksregierung Koln“Ranbaxy does not comply with the Good Manufacturing Practice Requirements referred to in the GMP Directive from the European Commission”. The regulator said that it revealed “unsatisfactory investigations into medial trials failures” along with deficiencies with Ranbaxy’s design and operation of its clean rooms as well as controls for the preparation and sterilization of its equipment and controls for its aseptic filling.
The National Competent Authority also said that Ranbaxy’s sterile products are non-compliant and its new GMP certificate for its Dewas India site does not include sterile products. Germany’s regulators have issued a non compliance report for the Dewas Facility where Ranbaxy manufactures cephalosporin antibiotics after an inspection in June 2014 for not complying with Good Manufacturing Practices.