Dr. Reddy’s Hopes U.S. FDA Visit Will Clear Mexico Production Facility
This article was originally published in PharmAsia News
Executive Summary
India-based Dr. Reddy’s Laboratories expects a visit by U.S. FDA inspectors at its production facility in Mexico by the end of March, a visit it hopes will lead to release of its products into the U.S.
Dr. Reddy’s Laboratories expects a visit by U.S. FDA inspectors at its production facility in Mexico by the end of March, a visit it hopes will lead to release of its products into the U.S. The agency issued an import alert on products from the facility last November after an inspection that questioned its process for making active pharmaceutical ingredients and steroids. Dr. Reddy’s agreed to correct the problems and said in a federal filing the FDA has informed the firm it plans a new inspection this month to see if the corrections have been made. (Click here for more
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“U.S. FDA May Visit Dr. Reddy’s Laboratories’s Mexico Facility This Month” – Economic Times (India) (3/20/12)