FDA to Inspect Dr. Reddy's Laboratories Ltd.'s Plant in Mexico
Published: Mar 20, 2012
Dr. Reddy's Laboratories Ltd. said it has been informed of an inspection by the U.S. Food and Drug Administration of its Mexico facility during the last week of this month. The drug regulator had in June last year banned imports into the U.S. of some active pharmaceutical ingredients and steroids made at Dr. Reddy's Mexico unit, citing violation of manufacturing practice rules. The company, in a filing with the U.S. Securities and Exchange Commission Monday, also said it is working collaboratively with the FDA to resolve the regulatory issues concerning the Mexican facility.