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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.
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July 20, 2015
06:04 EDTIARTSeaSpine selling pressure may be over, says at Piper Jaffray
Piper Jaffray points out that shares of SeaSpine (SPNE) are down 15% since their spin-off from Integra LifeSciences (IART) on June 17. Piper attributes the weakness to non-fundamental selling by existing Integra shareholders and its analysis indicates that the worst of the selling pressure might be over. The firm keeps an Overweight rating on SeaSpine with a $24 price target.
July 15, 2015
07:29 EDTIARTAmerican Orthopaedic Foot & Ankle Society to hold annual meeting
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