The US FDA has issued two warning letters to Ranbaxy following drug manufacturing concerns.

Ranbaxy Laboratories Ltd has announced the appointment of former New York City Mayor, Rudolph Giuliani, following recent actions by the US Food and Drug Administration (FDA) to ban a number of its products over manufacturing concerns.

The FDA’s actions relate to its findings of violations in certain areas of Ranbaxy’s Indian manufacturing facilities, including inadequate sterile processing operations and inaccurate written records of cleaning and use of major equipment. This has led to an import ban in the US for certain products manufactured within Ranbaxy’s India operations.

However, Ranbaxy commented in a statement that it was disappointed by the FDA’s actions: “We are, however, pleased that FDA’s testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy’s drugs. The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues.”

Ranbaxy is one of the largest foreign suppliers of generic drugs to the US and is the largest pharmaceutical company in India, and has production facilities in both countries. It employed Rudolph Giuliani following the FDA’s actions – Giuliani is Chairman and Chief Executive Officer of Giuliani Partners LLC, which he founded in 2002 and which advises companies on strategic issues, brand and reputation.

Click here to view an online a list of questions and answers for consumers of Ranbaxy products, published online by the FDA.