The FDA hit Lupin Ltd., of Mumbai, with a warning letter citing problems with how the company dealt with out-of-specification results at several of its drug manufacturing plants and set hold times that were inadequate to assure drug quality. "These repeated failures at multiple sites demonstrate that your company's oversight and control over the manufacture of drugs is inadequate," the FDA said. The agency instructed Lupin to immediately and comprehensively assess its global manufacturing operations to ensure that the systems and processes, as well as the drugs, conform to FDA requirements.