483
Stemell IncFDA 483 - Stemell Inc - March 08, 2019
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Record Details
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.
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ID · 6edda505-50ac-4e5a-bf68-abdc8f4591ef