FDA 483 - American CryoStem Corporation - July 26, 2017

This FDA Form 483 details observations from an inspection of a facility manufacturing stromal vascular fraction (SVF) and ATCell expanded mesenchymal stem cells (MSCs) biological drug products, with approximately (b)(4) batches of ATCell distributed since 2011.

Key violations include: 1. **Lack of Sterilization Process Validation:** Procedures to prevent microbiological contamination of sterile drug products do not include validation of aseptic processes for SVF isolation and MSC expansion. 2. **Absence of Process Validation:** No written procedures for production and process controls ensure drug product identity, strength, quality, and purity, as manufacturing processes for SVF and ATCell have not been validated. 3. **Deficient Environmental Monitoring:** A program for environmental monitoring for microorganisms in aseptic processing areas has not been established since operations began in 2011. 4. **Inadequate Component Supplier Reliability Validation:** Reliability of component suppliers' analyses (e.g., for (b)(4) and (b)(4)) is deficient, lacking at least one specific identity test and appropriate validation of supplier test results. 5. **Missing Component Sampling and Testing Procedures:** No written procedures exist for sampling and testing upon receipt of manufacturing components like (b)(4) and (b)(4). 6. **No Drug Product Stability Testing Program:** A written program to assess drug product stability characteristics is absent. 7. **Unvalidated Cleaning