FDA 483 - Stemell Inc - March 08, 2019

Stemcell Inc, a stem cell manufacturer in San Juan Capistrano, CA, received 18 observations during an FDA inspection. The firm was cited for significant deficiencies including a lack of validation for aseptic manufacturing processes, inadequate environmental and personnel monitoring, and poor aseptic techniques. Further issues involved absent quality control procedures, incomplete batch records, and a lack of stability data for their stem cell and exosome products.