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U.S. FDA Slams Warning Letter On Dr. Reddy's For GMP Violations At Mexico API And Steroids Site

This article was originally published in PharmAsia News

Executive Summary

MUMBAI - U.S. FDA issued a warning letter to India's Dr. Reddy's Laboratories Ltd. following investigations that detected adulterated APIs at its Cuernavaca, Mexico site. The regulatory agency noted "significant deviations" from current good manufactuirng practices at the site. The FDA probe centers around unvalidated analytical methods, deficiencies in handling out-of-specification investigations and parameters used to ensure cGMP compliance

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