FDA raises drug safety concerns at Hospira facility in India
May 30 (Reuters) - Hospira Inc said it received a warning letter from the U.S. Food and Drug Administration raising concerns about contamination of drugs manufactured at its facility in India.
The letter followed an October inspection of the facility in the southern Indian state of Tamil Nadu, where the FDA said it had found significant violations of quality regulations for finished drugs.
The FDA said it found that surfaces in the facility were not always sanitized prior to use and that sterile drug products were not protected from contamination. ()
Hospira entered into an agreement in August to buy a factory and research center from India-based Orchid Chemicals & Pharmaceuticals Ltd in a bid to reduce costs.
Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010, and withdrew its 2013 profit and revenue outlook in February after the FDA banned the import of some of its products.
Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy Laboratories and Wockhardt Ltd faced issues related to manufacturing practices.
Ranbaxy earlier this month agreed to pay $500 million in civil and criminal fines under a settlement agreement with the U.S. Department of Justice, after it pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations.
The FDA imposed an "import alert" on a plant operated by Wockhardt in the western state of Maharashtra on May 22.
- Israel strikes house of Hamas Gaza leader, digs in for long fight |
- West agrees wider Russia sanctions as Kiev says forces near crash site |
- U.S. says Russia violated nuclear treaty, urges immediate talks
- Judge gives go-ahead for $2 billion sale of NBA's Clippers
- Jaded Argentines brace for looming debt default