Indian generics maker Dr. Reddy’s Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed.
The U.S. Consumer Product Safety Commission contends that Dr. Reddy’s violated the Consumer Product Safety Act and the Poison Prevention Packaging Act by selling products between 2008 and 2012 that didn’t meet packaging requirements intended to prevent misuse by children, the company said in an Aug. 19 SEC filing.
The commission notified Dr. Reddy’s of the allegation in an April 30 letter and the two parties have been in discussions since, the drugmaker added.
Dr. Reddy’s said it disagrees with the accusations, but that it can’t guarantee a positive outcome from planned civil penalties the commission intends to pursue. The Department of Justice has launched its own parallel investigation in the matter under the Federal False Claims Act, the company added.
Illustrate for your employees six of the most common mistakes that lead to ruined batches, recalls, or worse. Focus on GxPs: A DVD Training Toolkit for Your Most Common and Costly Manufacturing Mistakes.