The FDA has warned Ranbaxy that two manufacturing facilities in India have deviated from the U.S. Good Manufacturing Practice (cGMP) requirements. An import alert has been issued and any active pharmaceutical ingredients or finished drug products manufactured at the two plants may be detained at the border.
At this time, there is no evidence that defective products have been shipped and the removal of any Ranbaxy products from the market is not necessary. This alert does not apply to Ranbaxy’s other facilities that have been FDA inspected and have met cGMP requirements for drug manufacturing.
For more information visit www.fda.gov/foi/warning_letters/s6922c.htm.