RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, announced that on Sept. 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 Oct. 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.
“The outcome of this inspection confirms that we have taken the necessary steps to significantly improve our environmental monitoring program,” said Brian K. Hutchison, president and CEO. “We hold ourselves to a higher standard because of the importance of the work we do for the medical community and on behalf of the donation community. We are committed to ensuring that we have the most robust environmental monitoring and quality control procedures in our industry to maintain our status as the industry leader in patient safety.”
The October 2012 warning letter did not restrict the company’s ability to process or distribute implants, nor did it require the withdrawal of any implants from the marketplace. The issues noted in the warning letter did not impact patient safety.