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News Breaks
February 19, 2013
16:10 EDTIARTIntegra LifeSciences receives warning letter from FDA
Integra LifeSciences Holdings announced that on February 14 it received a warning letter from the FDA related to quality systems issues at its manufacturing facility located in Aņasco, Puerto Rico. The letter resulted from an inspection conducted at that facility during October and November 2012. The Company has provided certain additional information relating to the matters set forth in this press release, as well as a copy of the warning letter as an exhibit in a Current Report on Form 8-K filed concurrently with the issuance of this press release. The warning letter cites concerns relating to process validations, corrective and preventative actions, and document controls. Integra believes that it has already substantially remediated the issues addressed in the warning letter, and is in the process of having third-party consultants assess its procedures and processes to ensure that products are manufactured in accordance with applicable regulations, as recommended by FDA.
News For IART From The Last 14 Days
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May 4, 2015
07:23 EDTIARTAmerican Association of Neurological Surgeons to hold annual meeting
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May 1, 2015
10:00 EDTIARTOn The Fly: Analyst Downgrade Summary
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10:00 EDTIARTOn The Fly: Analyst Upgrade Summary
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08:40 EDTIARTIntegra LifeSciences downgraded to Hold from Buy at Lake Street
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05:39 EDTIARTIntegra LifeSciences upgraded to Outperform from Market Perform at Wells Fargo
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April 30, 2015
16:41 EDTIARTIntegra LifeSciences raises FY15 adj EPS view to $3.15-$3.33 from $3.05-$3.23
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16:39 EDTIARTIntegra LifeSciences reports Q1 adjusted EPS 76c, consensus 63c
Reports Q1 revenue $233.7M, consensus $229.64M.

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