Hospira commented on the U.S. Food and Drug Administration re-inspection of the company's Rocky Mount, N.C., facility and the Form 483 detailing the associated observations. Additional information regarding the inspection was included in Hospira's Form 8-K filing on March 5, the company said, adding: "Hospira has been working diligently on quality improvement and remediation efforts to reinforce our foundation and position the company for growth. We have made good progress at Rocky Mount and believe that we have met to date the commitments that we have outlined to the FDA. While there is still work to be done, we intend to continue to work with the FDA to balance the advancement of our remediation and modernization efforts while continuing to deliver patient-critical products." Hospira said it is encouraged that a number of the observations are related to remediation efforts currently underway or issues that had been self-identified, and are slated to be addressed in the latter part of the plant's remediation and modernization plans. Additionally, based on the initial assessment of the 483 by Hospira and its consultants, the company continues to believe in the safety and efficacy of its products and is not anticipating any significant impact to its marketed products, it said. Hospira said it is in the process of sharing its response plan and associated corrective actions with the FDA.
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