Hospira (HSP) Discloses Receipt of FDA Warning Letter Following Costa Rican Facility Exploration
Tweet Send to a FriendGet Alerts HSP Hot Sheet
Down)
Trade HSP Now!
On August 23, 2012, Hospira, Inc. (NYSE: HSP) received a warning letter from the U.S. Food and Drug Administration (FDA) related to an inspection of the Company’s La Aurora de Heredia, Costa Rica device manufacturing facility from April 16, 2012 through April 19, 2012. The Costa Rica site manufactures most of the Company’s infusion devices and sets. A copy of the FDA’s warning letter is filed as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
The warning letter does not restrict production or shipment of the Company’s products from this facility. The Company is still in the process of evaluating what corrective actions, and associated costs, are required to address the matters raised in this warning letter.
The Company takes this matter seriously and intends to respond fully, and in a timely manner, to the FDA’s warning letter. Until the violations are corrected, the Company may be subject to additional regulatory action by the FDA, including 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.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
The warning letter does not restrict production or shipment of the Company’s products from this facility. The Company is still in the process of evaluating what corrective actions, and associated costs, are required to address the matters raised in this warning letter.
The Company takes this matter seriously and intends to respond fully, and in a timely manner, to the FDA’s warning letter. Until the violations are corrected, the Company may be subject to additional regulatory action by the FDA, including 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.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Novo Nordisk (NVO) Reports Positive Results from Paradigm 2
- Hospira Reappoints Dr. Sumant Ramachandra Chief Scientific Officer
- Zoetis (ZTS) Reveise FDA Approval of APOQUEL
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
