FDA Takes Harder Look at Indian Drugmakers
US inspectors visiting a factory in India owned by drugmaker Wockhardt in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six metres from the entrance to a sterile manufacturing area. And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration (FDA) to Wockhardt, which makes sterile injectable drugs and various forms of insulin.
India's drugmakers, battered by a rash of US regulatory rebukes, including a record fine for Ranbaxy Laboratories Ltd , face closer FDA scrutiny as the agency ramps up its presence in the country. Read the full story.