UPDATE: Hospira Gets FDA Warning Letter For Two Facilities
16 Abril 2010 - 7:18PM
Dow Jones News
Hospira Inc. (HSP) disclosed Friday that it recently received a
warning letter from the Food and Drug Administration related to
plants where it makes already-recalled dietary supplement and
anesthesia products that had issues with metal particles.
The products in question are called Liposyn and Propofol, which
Hospira voluntary pulled from the market in November. In a filing
with the Securities and Exchange Commission late Friday, Hospira
said the FDA letter covered facilities in North Carolina.
Warning letters can prove expensive and time-consuming to
resolve, and can also put a hold on FDA approval for products
related to issues the agency found. Hospira said this letter
doesn't restrict production or shipping at the North Carolina
plants, but the company is holding shipment of certain products
pending further investigation and discussion with the FDA.
Hospira shares slipped 1.7% in after-hours trading Friday to
$56.11. Shares declined 1.2% during regular trading hours.
The Lake Forest, Ill., company said it doesn't anticipate these
matters will adversely affect its ability to achieve its 2010
financial projections, although it said future regulatory action
from the FDA could have a material impact on results. The company
said it takes the matter seriously and intends to respond fully to
the agency.
The plants in question are in Clayton, N.C., and Rocky Mount,
N.C. In the SEC filing, Hospira said the letter involved
manufacturing deficiencies related to particulate found in products
made at the Clayton plant and failure to adequately validate
manufacturing processes at the Rocky Mount site.
The FDA letter also asserted inadequacies in Hospira procedures
that involve quality control, investigation and medical-device
reporting obligations, the company said.
"The letter asserts that some of the deficiencies were repeat
observations from a prior inspection conducted in April 2009, and
include a similar violation cited in an August 12, 2009 warning
letter to the Company's Morgan Hill, California facility," the
company said.
"The Company will be undertaking a comprehensive review of its
manufacturing operations to ensure compliance with applicable
regulations," Hospira said.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com
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