The FDA has come down hard in recent months on some of India's key generic drug makers, having taken actions against Indian plants operated by Wockhardt, Ranbaxy Laboratories and Agila Specialties. But Indian facilities operated by Western drugmakers have also been targets of citations, including one owned by Hospira ($HSP). The Irungattukottai plant, which was tagged with a warning letter in May, came up short of expectations during a recent follow-up inspection.
The Lake Forest, IL-based drugmaker did not say what problems were outlined in the Form 483 this time around but acknowledged them in a Dec. 20 filing with the Securities and Exchange Commission. It said most of the 23 observations had to do with processes and procedures and that it expected to get the majority of the observations addressed over the next several weeks. It said it didn't anticipate any interruption to its production. The inspection was completed Dec. 10.
While companies do not always publicize receiving Form 483s, Hospira said it acknowledged this one because the plant had received the earlier warning. That letter laid out a variety of shortcomings with sterility, including unsanitary surfaces, airflow questions and problems with the sterility of gloves worn by workers. In the letter, the agency ordered Hospira to create a corrective action plan for both its foreign and U.S. plants, including how it intends to train employees involved in aseptic processes. Hospira has already spent the last several years, and more than $300 million, addressing issues at three plants in the U.S. and has recently said it is close to resolving concerns with them.
Hospira is not the only Western drugmaker to face FDA action for problems at a plant in India. In a July 1 warning letter, the FDA cited an oncolytic API plant in Kalyani operated by Fresenius Kabi, the generic drug unit for the German healthcare company. The company fired some managers at the plant after FDA inspectors reported that employees lied about quality testing and also confessed that ahead of several FDA inspections, testing equipment and personal computers had been removed to "conceal data manipulations."
Indian production facilities make a reported 40% of the generic drugs prescribed in the U.S., but serious quality problems among some manufacturers there have led the FDA to add to its in-country inspection staff. The agency has indicated the expanded operation will not only help it do more inspections but also allow it to work with manufacturers there so they will understand FDA expectations and how to achieve them.