FDA WARNING_LETTER - SURGENEX LLC - April 16, 2021

An FDA inspection of Surgenex LLC from April 5-16, 2021, revealed significant violations regarding its cellular products, SurCord®, SurForce®, and SurFactor®, intended for orthopedic conditions. These products are classified as unapproved drugs and biological products, and HCT/Ps that do not meet 21 CFR 1271.10(a) criteria, requiring premarket review. Specifically, the products fail homologous use (21 CFR 1271.10(a)(2)) and minimal manipulation (21 CFR 1271.10(a)(1)) criteria. Crucially, no approved Biologics License Application (BLA) or Investigational New Drug (IND) application is in effect for any product, violating the FD&C and PHS Acts. The inspection also documented significant Current Good Manufacturing Practice (CGMP) deviations, posing potential safety concerns like microbial contamination. Deficiencies include failure to establish/follow procedures to prevent contamination and validate aseptic processes (21 CFR 211.113(b)), inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), lack of validated production/process controls (21 CFR 211.100(a)), failure to investigate sterility failures (21 CFR 211.192), and absence of a stability testing program (21 CFR 211.166(a)). Surgenex committed to ceasing manufacturing and distribution by May 28, 2021, until BLA/IND approval and CGMP compliance. However, the FDA deemed responses inadequate, noting continued distribution of non-compliant products despite safety concerns, and that enforcement discretion did not apply. The firm must address quarantined inventory and the impact on previously distributed products. Failure to correct these violations may lead to regulatory actions like seizure or injunction.