Infusion technologies maker Hospira (NYSE:HSP) remains in the FDA’s cross-hairs after agency inspectors asked for more information about a North Carolina manufacturing facility that has been in hot water for years.
In the new warning, FDA officials cited at least 1 device malfunction in the field associated with injection systems that failed leak testing but were nonetheless allowed on shelves. One of the devices in the product lot was labeled "non-conforming" during October 2012 testing, but that failure was deemed unrepresentative of the batch and the devices were sent to market anyway, inspectors said.
Regulators further chided Hospira for a lack of missing information regarding sterilization processes and complaint handling. Documentation regarding complaints, in particular, were a sticking point for FDA inspectors who said that there were missing records, complaints with "extended due dates" and insufficient assurances to protect against recurring problems.
Hospira responded to many of the inspectors’ inquiries, but the agency plans to follow up to verify that additional quality measures have been put in place and that they have sufficiently addressed the FDA’s concerns. The agency further asked for updates on specific complaints that inspectors said were associated with a recall of the company’s sterile empty vials.
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 2nd 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.*
HSP shares were up 0.5% today, trading at $42.88 as of about 4 p.m. The stock is up 3.9% since the start of the year.
*Correction: This article originally stated that the December 2013 communication was a warning letter. That communication was actually a Form 483.
