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HSP > SEC Filings for HSP > Form 8-K on 14-May-2013All Recent SEC Filings

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Form 8-K for HOSPIRA INC


14-May-2013

Other Events, Financial Statements and Exhibits


Item 8.01 Other Events

On May 14, 2013, Hospira, Inc. (the "Company") announced that Sumant Ramachandra, M.D., Ph.D., has been reappointed to his role as Senior Vice President and Chief Scientific Officer, effective May 17, 2013. A copy of the press release announcing this reappointment is attached as Exhibit 99.1, and is incorporated herein by reference.

In addition, on May 10, 2013, the Company received a warning letter from the U.S. Food and Drug Administration ("FDA") related to an inspection of the Company's device operations in Lake Forest, Illinois from January 29 through February 7, 2013. A copy of the FDA's warning letter is filed as Exhibit 99.2 and is incorporated herein by reference.

The Company takes this matter seriously and intends to respond fully in a timely manner to the warning letter. The Company does not expect that the warning letter will impact its 2013 financial guidance or the cost range associated with the Company's recently announced device strategy.

Until the violations are corrected, the Company may be subject to additional regulatory action by the FDA, including but not limited to, the withholding or delay of approval of 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 Company's response to the warning letter.

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 anticipated impact of the FDA's warning letter on the Company. The Company cautions that these forward-looking statements are subject to risks, uncertainties and assumptions, many of which are beyond the Company's 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, additional actions by or requests from the FDA. Additional information concerning other factors is contained under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K and subsequent Form 10-Q filed with the Securities and Exchange Commission, which are incorporated by reference. The Company undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.




Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.                  Description

99.1          Press Release, dated May 14, 2013
99.2          FDA Warning Letter, received May 10, 2013

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