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Home » FDA Hits Dr. Reddy’s With Warning for Repeat GMP, Data Integrity Issues
FDA Hits Dr. Reddy’s With Warning for Repeat GMP, Data Integrity Issues
The FDA has issued a lengthy warning letter to Dr. Reddy’s Laboratories for three India facilities — two in Andhra Pradesh and one in Telangana — for several data integrity and GMP issues that the agency says “represent long-standing failures to adequately resolve significant manufacturing quality problems.”