Hospira Hit with FDA Warning Over Infusion Pump Manufacturing Facility

Infusion pump maker, Hospira, was just hit with a federal warning over its Costa Rican manufacturing facility. The warning letter, issued by the U.S. Food & Drug Administration (FDA), followed a series of quality problems on which we have been writing.

The Costa Rican facility manufacturers most of Hospira’s infusion pumps, said Reuters. The warning followed an April inspection conducted by the agency and does not restrict production or shipments from the plant, located in La Aurora de Heredia. Hospira released the information in its regulatory filing with the U.S. Securities and Exchange Commission yesterday.

Hospira said it resumed production of injectable drugs at its Rocky Mount, North Carolina, plant, following a maintenance shutdown; manufacturing problems there led to drug shortages, including anesthesia medications, said Reuters.

The FDA cited ongoing problems with Hospira’s Plum brand infusion pump, which the firm recalled in February 2011. That recall involved the pump’s alarm; Hospira received alarm failure complaints even following a component redesign, said the agency in its letter. Hospira said it was considering actions and costs to address issues raised in the FDA letter. “It seems FDA, with this warning letter, is not fully satisfied with their efforts to correct the alarm problems,” Morningstar analyst Michael Waterhouse told Reuters.

Hospira’s new Chief Executive, Michael Ball, told analysts earlier this month, that the firm was progressing in its response to a number of manufacturing issues, said Reuters. A spokeswoman for Hospira said that it was switching alarm components for the pump and expects that process to be completed early next year. According to Reuters, Hospira has long been working on resolving manufacturing issues at some of its plants.

We recently wrote that Hospira, Inc. announced a recall of its Hydromorphone Injection due to overdose concerns. That recall involved one lot of Hydromorphone Injection and followed a reported complaint of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed, including respiratory depression (slowed breathing or suspension of breathing); low blood pressure; and reduced heart rate, including circulatory collapse.

We also recently wrote that Hospira Propofol was recalled, nationwide, for a vial defect involving three lots of Propofol Injectable Emulsion over to visible particles embedded in the glass at the user level. This may cause the potential for drug to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event particulate matter is injected into a patient, there exists the potential for patient injury requiring medical intervention. Risks include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function.

Hospira expanded a March 2010 recall of its Propofol Injectable Emulsion 1% and Liposyn (Intravenous Fat Emulsion) products because some recalled containers might have contained particulate matter primarily made up of subvisible inert stainless steel particles. And, in 2010, Hospira also recalled its Symbiq Infusion Systems One-Channel and Two-Channel Infusers, a recall deemed a Class I by the agency because of the potential for the device to fail to detect air in line at the end of an infusion, which could result in the delivery of air to the patient, which could lead to serious injury or death.

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