FDA investigating generics manufacturer for falsifying records

The DOJ filed a motion in U.S. District Court in Maryland seeking documents from Ranbaxy. The DOJ alleges the manufacturer was involved in adulteration and forgery of data it submitted to the FDA. In its filing, the DOJ alleged some of the products Ranbaxy manufactured were too strong, too weak, or lacked the proper shelf life, according to a(Newark) Star-Ledger article.

Ranbaxy filed a response Tuesday, saying it had been fully cooperating with investigators and had already turned over more than 100,000 documents. According to the response, Ranbaxy said its internal audits  wAccording to the response, Ranbaxy said its internal audits “will demonstrate that no data manipulation, fraud, or dishonesty occurred” in its regulatory filings with the FDA and it plans to continue cooperating with investigators and asked investigators to share more details of the alleged misconduct.