RTI Surgical® Announces Successful Outcome to FDA Inspection of Alachua,
ALACHUA, Fla. -- September 11, 2013
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
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
“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.
About RTI Surgical Inc.
RTI is a leading global surgical implant company providing surgeons with safe
biologic, metal and synthetic implants. Committed to advancing science, safety
and innovation, RTI’s implants are used in sports medicine, general surgery,
spine, orthopedic, trauma and cardiothoracic procedures and are distributed in
nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four
manufacturing facilities throughout the U.S. and Europe. RTI is accredited in
the U.S. by the American Association of Tissue Banks and is a member of
AdvaMed. For more information, please visit www.rtix.com.
RTI Surgical Inc.
Jenny Highlander, APR, 386-418-8888
Manager, Corporate Communications
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