Smart Surgical, Inc dba Burst Biologics
FDA issued a warning letter to Smart Surgical, Inc. dba Burst Biologics (Boise, ID) regarding its BioBurst Fluid and BioBurst Rejuv products derived from human umbilical cord blood, which FDA determined are unapproved biological drugs lacking a valid biologics license application (BLA) or investigational new drug (IND) application. The company's website marketing indicated the products were intended to treat various diseases and conditions, and the products failed to meet the homologous-use and other criteria required for regulation solely under section 361 of the PHS Act. FDA also documented serious CGMP/CGTP deviations including deficient donor screening (Zika virus risk), unvalidated aseptic processes, inadequate environmental monitoring, and numerous uninvestigated sterility failures. FDA warned that failure to address these violations may result in seizure and/or injunction.
Flagged claims (2)
your products are intended to treat various diseases or conditions
your products are intended to be applied to surgical and injury sites to supplement tissue defects and for orthopedic use, and your products could be administered via intra-articular injection
Required actions (2)
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 address any 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.
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