FDA issues warning letters and import alert for drugs from two Ranbaxy plants in India

The US FDA has issued two Warning Letters to Ranbaxy Laboratories, of India, and an Import Alert for generic drugs produced by Ranbaxy at two plants in India.

The Warning Letters identify the agency's concerns about deviations from cGMP requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit). Products from Ranbaxy's other plants are not affected. FDA has inspected those facilities and, to date, they have met US cGMP requirements for drug manufacturing.

Because of the extent and nature of the violations, FDA issued an Import Alert, under which US officials may detain at the border API and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities.

The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. The actions are proactive measures and do not involve removing products from the market. The FDA has no evidence to date that Ranbaxy has shipped defective products but will continue to monitor the situation.

Ranbaxy is one of the largest foreign suppliers of generic drugs to the US. The Import Alert covers more than 30 generic drug products produced in multiple dosage forms and dosage amounts at the two locations. FDA has evaluated whether these actions would create any potential drug shortages in the US and has determined that other suppliers can meet market demand, with one exception.

Because Ranbaxy is the sole supplier to the US of Ganciclovir oral capsules FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.