FDA 483 - US Stem Cell Clinic, LLC - May 11, 2017

The FDA Form 483 details numerous deficiencies at a facility manufacturing injectable Stromal Vascular Fraction (SVF) from autologous adipose tissue, with at least (b)(4) batches produced between 12/08/2015 and 04/17/2017. The SVF product is administered via various methods including intrathecal, intravenous, intradiscal, intramuscular, or intra-articular.

Key violations include: - **Lack of Aseptic Process Control:** No established, written, or followed procedures to prevent microbiological contamination, and the aseptic manufacturing process is not validated. This is a repeat deficiency. - **Inadequate Product Testing:** Failure to perform sterility and endotoxin testing on at least (b)(4) batches of injectable SVF product. This is a repeat deficiency. - **Environmental Monitoring Deficiencies:** No environmental monitoring in the aseptic processing area. - **Cleaning and Disinfection Issues:** Use of non-sterile disinfectants and wipes, lack of sporicidal agents, no established cleaning/maintenance procedures for equipment, and observed dust accumulation on air vents. Records of equipment cleaning/sanitizing are lacking. These are repeat deficiencies. - **Unsuitable Equipment:** Use of a (b)(4) (b)(4) model (b)(4) not certified for sterile compounding applications. - **Inappropriate Personnel Gowning:** Employees processing injectable SVF use non-sterile masks