Dr. Reddy’s Laboratories, one of the world’s largest generic drugmakers, 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.
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 reproducability.
These were among the findings in a so-called 483 report that is generated after FDA inspectors visit a facility and cite a company for manufacturing violations. In this instance, the agency found 10 infractions following an inspection during the last two weeks in October at a biologics manufacturing facility in Bachupally, Hyderabad.