Surgenex LLC
FDA issued a warning letter to Surgenex LLC (Scottsdale, AZ) regarding its manufacture and distribution of three allogeneic HCT/P products — SurCord®, SurForce®, and SurFactor® — derived from umbilical cord and amniotic membrane and marketed for orthopedic conditions. The products were found to be unapproved biological drugs lacking a valid biologics license application or IND, and failed to meet homologous-use and minimal-manipulation criteria under 21 CFR 1271.10(a). FDA also documented significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, uninvestigated sterility failures, and unsupported expiration dating, raising potential significant patient safety concerns. FDA demanded a written response within 15 working days and warned that failure to correct violations may result in seizure and/or injunction.
Flagged claims (2)
your products are intended for use to treat diseases or conditions, including a variety of orthopedic diseases or conditions
These products are intended for injection and are purported to be sterile.
Required actions (3)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations and prevent their recurrence.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
Surgenex has ceased manufacturing of these three product lines [SurCord®, SurForce®, and SurFactor®] effective April 16, 2021 and, will cease distribution in a responsible manner to our health care providers and the patients they treat. In any case, no SurForce, SurFactor, or SurCord allografts will be distributed past May 31, 2021
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