MASSDEVICE ON CALL — Drug pump maker Hospira (NYSE:HSP) was the subject of another FDA warning letter posted this month, in which FDA officials asked for more information about steps taken to address quality control violations.
Inspectors asked Hospira to provide copies of memos and detailed documentation and to take additional steps to address concerns about leak-testing in drug delivery systems and records and handling of complaint investigations.
"Your firm should take prompt action to correct the violations addressed in this letter," the federal watchdog agency cautioned. "Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice."
The latest warning letter follows a Form 483 issued to Hospira just last month over many of the same issued addressed in the latest communication.
Hospira has responded to many inquiries, but the FDA has said that it plans to follow up to verify that additional quality measures have been put in place.
The N.C.-based facility was previously the subject of a 3-week inspection which was, in turn, the result of an FDA inquiry reaching as far back as 2010. The latest warning letter is also the 3rd FDA communication Hospira has unveiled in recent months, following a December 2013 Form 483 that cited more nearly 2 dozen "observations" from an inspection of a facility in India.
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