Hospira Inc, a hospital products maker that has struggled with regulatory issues at manufacturing plants for the past year and a half, said it had received a notice over the quality of its medical devices from the U.S. Food and Drug Administration, according to Reuter’s.
The company reported the notice during a conference call last month after announcing a profit for the fourth quarter vs a year-earlier loss as sales of generic injectable drugs, IV solutions, drug pumps and other products increased more than 8 percent.
Hospira said the FDA completed an inspection of its medical device quality systems at its headquarters in Lake Forest, Illinois, last month and issued a list of 10 objectionable conditions. The list is known in the industry as a Form 483.
Some of the quality systems assessed as part of the Lake Forest inspection included supplier quality systems and medical device reporting and complaint systems, a Hospira spokeswoman said.
The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.
Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections, the spokeswoman said.
“While there may still be additional device field notifications going forward, we do not believe they will continue at the rate we have seen recently,” she said in an email.
Chief Executive F. Michael Ball said that FDA inspectors acknowledged some progress since the last inspection.
“The observations re-enforced our own assessment there is still a lot of work to be done within our device operations,” Ball said on the conference call.
Ball did not provide any specific details that were outlined in the 483, only said it was “particularly rough” though he said “many” of the observations were a repeat from an inspection that took place in July 2012.
He said management had been doing a complete review of all of its medical devices even before the FDA notice. He said they are developing a new longer term MMS (Medication Management Systems) strategy that would be “aimed at modernizing and streamlining platforms to best address our customer needs and the nearer-term remediation issues” and include input from the FDA.
Ball said there has been progress at some of its other manufacturing facilities that have had problems, including its Rocky Mount facility in North Carolina. Ball said a reinspection by the FDA would be extensive and lengthy but he expects to increase production this year.
He said Hospira’s other plants emerged from shut downs on schedule, such as the plant in Clayton, North Carolina. The Clayton facility has resumed manufacturing propofol, an anesthesia that is administered intravenously and has been in short supply, and is building inventory in the fourth quarter of 2012 for an early 2013 relaunch.
He said the drug was being priced at a premium.
Despite the costly remediation efforts and manufacturing issues, Hospira still reported an 8 percent fourth quarter increase in 2012 in comparison to the same quarter for 2011.