- Current report filing (8-K)
16 Abril 2010 - 5:29PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
April 13, 2010
Date of Report (Date of Earliest Event Reported)
HOSPIRA, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
1-31946
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20-0504497
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(Commission File
Number)
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(I.R.S. Employer
Identification No.)
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275 N. Field Drive
Lake Forest, Illinois 60045
(Address Of Principal Executive Offices, including Zip Code)
Registrants Telephone Number, Including Area Code:
(224) 212-2000
Not Applicable
(Former Name or Former Address, If Changed Since Last Report)
Check the appropriate box
below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o
Written communications pursuant to Rule 425
under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant
to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant
to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01
Other
Events
On
April 13, 2010, Hospira, Inc. (the Company) received a warning
letter, dated April 12, 2010, from the U.S. Food and Drug Administration
(FDA) in connection with the FDAs inspection of the Companys pharmaceutical
and device manufacturing facilities located in Rocky Mount, North Carolina and
Clayton, North Carolina.
In
the warning letter, the FDA cites Current Good Manufacturing Practice
deficiencies related to particulate in certain emulsion products at the Clayton
facility and the failure to adequately validate the processes used to manufacture
the Companys products at the Rocky Mount facility. The letter also asserts
other inadequacies, including the Companys procedures related to the Quality
Control unit, investigations, and medical device reporting obligations. 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 Companys Morgan Hill,
California facility.
The
Company will be undertaking a comprehensive review of its manufacturing operations
to ensure compliance with applicable regulations. The warning letter does not
restrict production or shipment of the Companys products from these facilities,
but the Company is holding shipment of certain products pending its further
investigation and discussions with the FDA. The Company does not anticipate
that these matters will adversely impact the Companys ability to achieve the
2010 financial projections communicated with the full year 2009 earnings
release.
The
Company takes this matter seriously and intends to respond fully, and in a
timely manner, to the FDAs warning letter. Until the violations are corrected,
the Company may be subject to additional regulatory action by the FDA,
including the withholding of approval of new drug applications, seizure,
injunction, and/or civil monetary penalties. Any such actions could
significantly disrupt our ongoing business and operations and have a material
adverse impact on our financial position and operating results. There can be no
assurance that the FDA will be satisfied with the Companys response.
The warning letter will be posted on the FDAs website at
www.fda.gov and, once posted, will be available for viewing.
Private Securities Litigation Reform Act of 1995
A Caution Concerning Forward-Looking Statements
This
Form 8-K contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements
regarding the impact of the FDA warning letter on the Companys 2010 financial
projections and statements regarding the Companys ability to resolve these
matters. The Company cautions that these forward-looking statements are subject
to risks, uncertainties and assumptions, many of which are beyond Hospiras
control, that may cause actual results to differ materially from those
indicated in the forward-looking statements, for a number of reasons, including
without limitation, delays in responding to the FDA, additional
2
requests
from the FDA, and unanticipated costs or delays associated with the resolution
of these matters. Additional information concerning other factors is contained
under the headings Risk Factors and Managements Discussion and Analysis of
Financial Condition and Results of Operations in Hospiras latest Annual
Report on Form 10-K filed with the Securities and Exchange Commission,
which are incorporated by reference. Hospira undertakes no obligation to
release publicly any revisions to forward-looking statements as the result of
subsequent events or developments.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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HOSPIRA,
INC.
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Dated:
April 16, 2010
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/s/
Brian J. Smith
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By:
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Brian
J. Smith
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Its:
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Senior
Vice President, General Counsel
and Secretary
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3
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