Hospira (NYSE:HSP) heard from the FDA’s inspection office this week with another warning that the infusion device company’s India facility still contains significant violations of good manufacturing practice regulations.
The FDA originally inspected the Industrial Park, Irungattukottai, Sriperumburdur, India facility in October 2012 and found serious problem with workplace sanitation, product sterility and processing violations that meant the products coming out of that plant were considered adulterated under law.
Inspectors were not satisfied with Hospira’s attempt to correct the problem, and sent another warning letter late last month. Hospira officials now have to send the FDA a clean-up plan within 30 days or the agency might ban imports or refuse all new device review applications, according to an agency warning.
The FDA also expressed concerns that manufacturing problems could lead to drug shortages, and instructed the company to contact the Drug Shortage Program immediately so that "we can work with you on the most effective way to bring your operations in compliance with the law," according to the letter.
The Lake Forest, Ill.-based company has been the target of several warning letters and facility inspections in the past year, including a 3-week inspection of a Rocky Mount, N.C., facility, which has been under the watchdog agency’s eye since an April 2010 warning letter
Hospira mainly sells injectable drugs and infusion devices, and recently took a $134 million hit during the 1st quarter because of a plan to “retire” some of its older, trouble-plagued infusion pumps and lowered sales and earnings expectations.
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