RTI Surgical says FDA completes new inspection
Published: Wednesday, September 11, 2013 at 10:35 a.m.
Last Modified: Wednesday, September 11, 2013 at 10:35 a.m.
ALACHUA, Fla. — Shares of orthopedic implant maker RTI Surgical rose modestly Wednesday after the company said that its processing facility passed a recent inspection by the Food and Drug Administration.
RTI Surgical said the FDA inspected the facility Monday and Tuesday and did not find any problems.
The company received a warning letter from the FDA in October following a previous inspection. The warning was related to environmental monitoring activities in areas of the processing facility. It did not affect its ability to process or distribute implants and it did not have to take any products off the market. RTI said the problems did not affect patient safety.
The FDA has determined that it has addressed its problems from the last inspection and the agency did not identify any new problems, RTI said.
RTI Surgical Inc. shares rose 23 cents, or 6.6 percent, to $3.74 in morning trading. The company changed its name from RTI Biologics in July.