RTI Surgical, provider of orthopedic and other biologic implants, has received a positive feedback from the US Food and Drug Administration (FDA), following its two- day inspection at its Alachua processing facility in Florida.
Earlier 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 several corrective actions in mid to late 2012 to improve the overall environmental monitoring within the facility.
The FDA found these actions to be adequate during its two-day inspection, and the company expects a close-out letter to be issued.
RTI Surgical president and CEO Brian K Hutchison noted the outcome of this inspection confirms that company has taken the necessary steps to significantly improve our environmental monitoring program.
"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," Hutchison added.
"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."