A German government's drug regulating agency, which audited one of Dr Reddy's Laboratories manufacturing facilities here, found "dirty rooms and equipment", among other violations, during an inspection. "Major deficiencies: (only examples are given for sub-items related to 5 major deficiencies)...3. cleaning of rooms and equipment. (9 sub-items) 3.1 dirty rooms and equipment 3.2 integrity of cleaning-documentation 3.3 cleaning-status labeling 3.4 status-label 'clean' of uncleaned equipment 3.5 dedicated-equipment labeling 4. validation of manufacturing process. (4 sub-items)...," the regulator said as nature of non-compliance in its report. Dr Reddy's Global Generics segment's revenues from Europe are primarily derived from Germany, the United Kingdom and out-licensing business across Europe.

Source: dna October 29, 2017 05:37 UTC