STAT+: FDA cites Dr. Reddy’s for quality control problems at a biologics plant
Dr. Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the FDA for a host of manufacturing violations at one of its plants in India.
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.
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