FDA cites Dr. Reddy’s for quality control problems at biologics plant, STAT says

Dr. Reddy’s Laboratories was cited by the U.S. Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems, STAT News’ Ed Silverman reports. In a recent inspection report, the agency found several notable failures, such as major production equipment that was not appropriately cleaned; a quality-control unit that did not investigate consumer complaints; computer systems that were not properly overseen; production buildings that were not maintained; and testing methods that were not established to detect accuracy or reproducibility, the author notes.