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RTI Surgical Inc Announces Outcome To FDA Inspection Of Alachua, Fla. Facility

Wednesday, 11 Sep 2013 08:00am EDT 

RTI Surgical Inc announced that on September 9 and 10 the Food and Drug Administration (FDA) performed an inspection of the company's Alachua, Fla. facility to verify effective implementation of the corrective actions taken after the company received a warning letter in October 2012. Upon completion of the inspection, inspectors noted the adequacy and effectiveness of the voluntary corrective actions and acknowledged the significant improvement in RTI's overall environmental monitoring program. All items in the warning letter were closed, and no new items, issues or FDA 483 observations were issued as part of this inspection. On October 23, 2012 the company received a warning letter from the FDA related to environmental monitoring activities in certain areas of its Alachua, Fla. processing facility. In response to the FDA`s observations, the company implemented a series of voluntary corrective actions to improve the overall environmental monitoring within the facility. The corrective actions were implemented in mid to late 2012. The FDA found these actions to be adequate during its two-day inspection, and the company expects a close-out letter to be issued. 

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-0.07 -1.10%
2 Jul 2015