FDA WARNING_LETTER - Smart Surgical, Inc - March 05, 2021

The FDA issued a Warning Letter to Smart Surgical, Inc., dba Burst Biologics, following an inspection from February 22, 2021, to March 5, 2021. The firm manufactures BioBurst Fluid and BioBurst Rejuv from human umbilical cord blood for allogeneic use, distributed as sterile injectable products. The FDA determined these products are unapproved drugs and biological products under the FD&C Act and PHS Act, not solely HCT/Ps, because they are not for homologous use and are dependent on living cells for their primary function without meeting specific exceptions.

The company lacks an approved biologics license application (BLA) or an investigational new drug (IND) application. Significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP) were observed, posing safety concerns. Violations include: 1. **Failure to determine donor ineligibility:** Donors from Zika virus risk areas were not deemed ineligible. 2. **Inadequate aseptic process validation:** No media fill simulations were conducted until October 2019, and subsequent simulations were insufficient (e.g., inadequate incubation times). 3. **Inadequate environmental monitoring:** Personnel monitoring excursions were not investigated, and action limits for microbial contamination were too high. 4. **Failure to test components:** Components were not sampled and tested by the quality control unit before use. 5. **Failure to investigate discrepancies