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.
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.
Read more: Hospira's India plant disappoints the FDA again - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/hospiras-india-plant-disappoints-fda-again/2013-12-30#ixzz2pIQuleDF
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