RTI Surgical, Inc. dba RTI Biologics, Inc. – FDA Warning Letter, Apr 28, 2017

This FDA Warning Letter, dated November 8, 2017, addresses RTI Surgical, Inc. (RTI) following an inspection from April 3-28, 2017, concerning their (b)(4) Bone Graft Product. The FDA determined the product, a human cell, tissue, or cellular or tissue-based product (HCT/P), is not regulated solely under section 361 of the PHS Act and 21 CFR Part 1271. This is because its processing, involving (b)(4) and (b)(4) to (b)(4), constitutes more than minimal manipulation (21 CFR 1271.3(f)(2)), and the product's primary function depends on the metabolic activity of living cells, not intended for autologous or closely related allogeneic use (21 CFR 1271.10(a)(4)(ii)(b)).

Consequently, the (b)(4) is regulated as a drug and biological product, requiring an approved biologics license application (BLA) or an investigational new drug (IND) application, neither of which RTI possesses. This constitutes violations of the FD&C Act and PHS Act.

The inspection also revealed significant deviations from current Good Manufacturing Practice (CGMP) and general biological product standards (21 CFR Parts 210, 211, and 61