Ranbaxy Labs Import Alert Disaster – 35% Stock Crash – Caused By Arm Hair?
September 18th, 2013 // 9:18 pm @ jmpickett
An FDA audit for a facility in India for Ranbaxy Laboratories determined that a black fiber that was embedded in a tablet was most likely an arm hair, according to the FDA 483 report.
That and other serious cGMP quality problems led FDA to set up an import alert on the Mohali, India plant. The alert from the agency noted that the biggest generic drugmaker in the country had no ensured cGMP quality.
Ranbaxy is currently owned 63% by Daiichi Sankyo, and gets about 45% of its sales in the US.
FDA’s import alert is a devastating blow to Ranbaxy, which has been hammered by several FDA regulatory actions, even as demand for generics grow in the US.
During an FDA inspection, the agency concluded that a black fiber that was in the tablet was either the remnants of tap on a machine nozzlehead, or a hair from someone’s arm that was exposed when the machine was loaded. This cGMP audit also found that some tablets were not within spec as far as specified weight limit.
FDA further found that there was dirty glassware, abrasions and spots on tablet surfaces and a failure in the packaging line that sent bottles that were unlabeled to pharmacies.
The import alert disallows Ranbaxy from making FDA regulated products at the plant in Mohali, and selling them in the US, until the controls, methods and facilities are in full cGMP compliance. One of the drugs that this plant intends to sell in the US is a generic type of Diovan, which is a popular blood pressure treatment.
A spokesperson for Ranbaxy stated yesterday that it has yet to get any communication from FDA about the import alert. FDA issued an import alert on two other facilities of Ranbaxy’s back in 2009. It stated at the time that the company’s cGMP standards were below FDA requirements. Those import alerts still stand.
At this time, India produces almost 40% of the generic drugs and OTC products in the US.
