RTI Surgical (NSDQ:RTIX) today revealed a warning letter it received from the FDA related to processes used to manufacture its Map3 cellular allogeneic bone graft over issues with the regulatory classification of the product.
The Alachua, Fla.-based company said it received the letter on November 9 based on an inspection of its facilities from April and that it is preparing an appropriate response to the letter.
In the letter, the FDA asserted that the Map3 allograft could not be regulated solely as a human cell, tissue and cellular and tissue-based product, but that the product was also subject to regulations applicable to drug and biological products that its current Map3 products “does not fully satisfy.”
RTI Surgical said that it “continues to believe the Map3 allograft meets the definition of, and may be regulated solely as, an HCT/P,” according to an SEC filing. The company said it plans to provide the FDA with its rationale as to why it should be regulated singularly as an HCT/P product.
“The company intends to respond fully to the issues raised by the FDA and to work diligently and expeditiously to resolve such issues,” RTI Surgical wrote in an SEC filing.
The letter also includes observations related to a Form 483 from the federal watchdog following the April inspection, but also noted corrections the company had taken to “address the majority of the observations in the Form 483.”
“The company cannot, however, give any assurances that the FDA will be satisfied with its response to the Warning Letter or as to the expected date of the resolution of the matters included in the Warning Letter. Until the issues in the Warning Letter are resolved to FDA’s satisfaction, the company may be subject to legal or regulatory action,” RTI Surgical wrote in an SEC filing.
Shares in RTI Surgical are down 1.6% so far today, at $4.63 as of 11:13 a.m. EST.
Earlier this month, RTI Surgical saw shares rise after it met expectations on Wall Street with its 3rd quarter earnings results.