The 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.
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.”
