J&J Not Only Drug Maker Firm With Manufacturing Troubles
Yet more evidence emerges that Hospira (HSP) has systemic problems at its various manufacturing facilities. The drugmaker yesterday disclosed that the FDA has issued yet another warning letter, but this time to a plant that was previously not on the agency radar. The plant is based in Costa Rica and makes infusion devices, and while no restrictions have been placed on shipments, there were a host of quality problems found during an April inspection.
The FDA missive is only the latest signal that Hospira may face a consent decree for its myriad manufacturing gaffes. Over the past two years, the agency uncovered a host of quality control issues at plants in North Carolina, Colorado and Texas, prompting warning letters and 483 inspection reports (see earlier Pharma news). Meanwhile, many Hospira medications now appear on the FDA drug shortages list (see here).
Although Hospira management recently told Wall Street analysts that good progress was being made in resolving the problems, the drugmaker had already spent $235 million on remediation and forecast this could reach as much as $375 million, according to RBC Capital Markets analyst Shibani Malhotra. But that likely did not include the corrective actions that must now be undertaken at the Costa Rica facility, according to Leerink Swann analyst Jason Gerberry.
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