By Debra Sherman
Feb 13 (Reuters) - Hospira Inc, a hospital products
maker that has grappled with regulatory issues at manufacturing
plants for the past 18 months, said it had received a notice
over the quality of its medical devices from the U.S. Food and
Drug Administration.
The company reported the notice during a conference call on
Wednesday 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.
Shares in Hospira fell $2.05 to $32.90 in afternoon trading
on the New York Stock Exchange.
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.
He said management had been doing a complete review of all
of its medical devices even before the FDA notice. He said the
new strategy would be aimed at modernizing and streamlining
platforms.
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 it
increase production this year.
He said Hospira's other plants emerged from shut downs on
schedule.
Hospira's Clayton, North Carolina 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.
Hospira said it expects sales to rise 1 percent to 3 percent
for 2013, and adjusted earnings per diluted share to be between
$2.05 and $2.20.
Management said the relatively wide range is based on the
expected rate of supply recovery and share gains, as well as
improvements in quality and manufacturing performance.
In the fourth quarter, its net income was $5.3 million, or 3
cents per share, in the latest quarter, compared with a net loss
of $214.0 million, or $1.30 per share, in the year-earlier
period.
Adjusted earnings were 55 cents per share. On that basis,
analysts on average were expecting earnings per share of 54
cents.
Net sales rose to $1.1 billion in the quarter from $1.0
billion a year before.
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