RTI Surgical Announces Successful Resolution to FDA Warning Letter for Alachua, Fla. Facility
Published: Oct 30, 2013
RTI Surgical Inc. (RTI) (RTIX), a global surgical implant company, announced today that the company has received a close-out letter from the Food and Drug Administration (FDA) verifying effective implementation of the corrective actions put in place following the warning letter the company received in October 2012.
The close-out letter follows an inspection in September 2013 by the FDA at the Alachua, Fla. facility where inspectors noted the adequacy and effectiveness of the voluntary corrective actions and acknowledged the significant improvement in the overall environmental monitoring program. The receipt of the close-out letter confirms that all items in the warning letter were closed, and no new items, issues or FDA 483 observations were issued as part of the follow-up inspection.
“Although patient safety was never in question, we are pleased to have received a close-out letter and for the successful resolution to the warning letter,” said Brian K. Hutchison, president and chief executive officer. “We take very seriously our commitment to patient safety and the confidence of surgeons who use our implants and we are committed to ensuring that we have the most robust environmental monitoring and quality control procedures in our industry. With more than five million implants distributed with zero incidence of implant-associated infection, we maintain our status as the industry leader in 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.
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management's beliefs and certain assumptions made by our management. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company's SEC filings may be obtained by contacting the company or the SEC or by visiting RTI's website at www.rtix.com or the SEC's website at www.sec.gov.
Contact: RTI Surgical Inc.
Jenny Highlander, APR, 386-418-8888
Manager, Global Communications
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