FDA 483 - California Stem Cell Treatment - July 26, 2017

The FDA Form 483 details numerous deficiencies at a facility manufacturing autologous SVF product. Key violations include the lack of established and followed procedures to prevent microbiological contamination of sterile drug products, specifically the failure to validate aseptic manufacturing processes through media fills and to validate sterilization processes for reusable instruments. Manufacturing supplies and processing containers (syringes) were repeatedly exposed to uncontrolled environments.

The firm failed to perform sterility testing on approximately batches of autologous SVF product manufactured from April 2015 to July 2017, and did not follow procedures requiring confirmation of results for SVF mixed with other substances. Aseptic processing areas lacked environmental monitoring, including nonviable particulate, active/passive air, and personnel monitoring.

Identity testing for components used in SVF manufacturing was not performed, and scientifically sound specifications, sampling plans, and test procedures for components and in-process materials were absent. The firm failed to assure components were free of extraneous matter, not discolored, and used within expiry. Written in-process and release criteria for SVF product, including specifications for calculations, were not established.

Batch production and control records were deficient, lacking documentation of significant manufacturing steps, specific component lot identifiers, equipment used, preparation details, start/stop times for processes, and personnel performing steps. Written procedures for component receipt, identification, storage, handling, sampling, testing, approval, and rejection were lacking.

The firm failed to determine the safety and stability of SV