RTI Surgical spikes after dodging FDA warning

RTI Surgical spikes after dodging FDA warning

Florida-based RTI Surgical (NSDQ:RTIX) announced this week that a new inspection of its manufacturing facility confirmed that the company had taken the appropriate actions to correct issues cited in an FDA warning letter issued last year.

The announcement sent RTIX shares up 12% by around 4 p.m. after the announcement on Wednesday, September 11, when they were trading at $3.93, up from an open price of $3.56.

In October 2012, when RTI Surgical was still known as RTI Biologics, FDA inspectors cited the company for manufacturing violations at its Alachua, Fla., facility. The cited violations didn’t impact patient safety and didn’t result in any manufacturing restrictions.

RTI implemented a series of correction actions to "improve the overall environmental monitoring within the facility," landing the agency’s approval during a 2-day follow-up inspection, the company said.

"The outcome of this inspection confirms that we have taken the necessary steps to significantly improve our environmental monitoring program," RTI president & CEO Brian Hutchinson said in prepared remarks. "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."

RTI was reborn this year after announcing in June its $130 million acquisition of Pioneer Surgical, maker of metal and synthetic orthopedic implants. RTI said at the time that the merger fits within the company’s long-term strategy to add metals and synthetic devices to its product portfolio, including synthetic biologics and allograft and xenograft implants. RTI also absorbed Pioneer’s distribution organization, which presents opportunities for cross distribution.

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