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The U.S. Food & Drug Administration issued a warning letter to India’s Ipca Laboratories after U.S. inspectors discovered that the drug company breached manufacturing regulations at three of its plants. The letter insinuates that Ipca’s management was aware of, and even encouraged, noncompliance. For instance, during the inspection of Ipca’s Ratlam facility, a quality lab employee told an FDA inspector that “if we find a failure, we set back the date/time setting and reintegrate to achieve passing results.” FDA inspectors also found “multiple examples of [Ipca’s] practice of back dating and falsifying laboratory data.” Ipca will not be able to introduce new drugs to the U.S., and Ipca products that are currently authorized for U.S. sale may be banned, the letter says.
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