In Feb 2009, the FDA halted a review of importation applications for generic drugs manufactured at Ranbaxy’s Paonta Sahib plant owned by Ranbaxy Laboratories, LTD, the Indian generic drug manufacturer, “due to evidence of falsified data.” According to the FDA press release, Ranbaxy “falsified data and test results in approved and pending drug applications.” Not only were seven different examples of false statements made by Ranbaxy to the FDA in their warning letter – this was the third time the facility had run afould of fed Food and Drug laws.
The FDA did include a caveat in its release, stating that the agency “has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.” But just a week after the FDA announced it was halting review of Paonta Sahib applications, Canada announced it was “quarantining” all drugs produced at the Paonta Sahib plant.
Previously, in September 2008, the FDA issued warning letters to Ranbaxy regarding “significant deviations” from FDA standards for the manufacture of drugs sold in the United States. According to an FDA press release, the agency also banned the importation of any Ranbaxy drugs produced at the company’s Dewas and Paonta Sahib plants.
According to the release, the Dewas plant’s cross-contamination prevention program was “insufficient.” These programs are designed to prevent cross-contamination between different types of drugs. The plant also used “inadequate” sterilization procedures and performed “inadequate failure investigations.” According to the FDA release, failure investigations are performed “to address any manufacturing control or product rejection to determine the root cause and prevent recurrence.” The Paonta Sahib plant had “inaccurate” records regarding cleaning and maintaining of its equipment and “incomplete” records.
Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, announced that the “severe violations” had led the FDA to ban importation of drugs from these plants and to deny any new drug import applications for drugs manufactured at these plants.
Before the warning letters were sent and the sanctions put in place, Ranbaxy had the opportunity to rectify the problems at the Dewas and Paonta Sahib plants; however, the company’s “response failed to adequately address multiple, serious deficiencies.”
Again – please read our full report at Wake-Up Wal-Mart.