May 30 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
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
The FDA imposed an "import alert" on a plant operated by
Wockhardt in the western state of Maharashtra on May 22.