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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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August 26, 2015
07:18 EDTIARTIntegra DFU study results positive in aggregate, says Piper Jaffray
Piper Jaffray analyst Matt O'Brien stated after Integra LifeSciences' DFU data was published that some competitive products have better metrics in certain areas. However, all told, O'Brien views the results positively and expects Integra to have one of the best wound care portfolios in the market once this product is cleared and reimbursed sometime next year, he tells investors in a research note. The analyst kept an Overweight rating and $72 price target on Integra shares, which closed up 39c to $59.25 yesterday.
07:13 EDTIARTIntegra LifeSciences announces online publication of FOUNDER study results
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