FDA 483 - California Stem Cell Treatment Center, Inc - July 27, 2017

This FDA Form 483 details numerous violations at a Beverly Hills facility manufacturing autologous Stromal Vascular Fraction (SVF) and a (b)(4) product, administered via various routes including intravenous and injection.

Key deficiencies include: - **Lack of Validated Procedures:** No written procedures for production and process controls, specifically failing to validate manufacturing processes for both SVF and (b)(4) products. - **Microbiological Contamination Prevention:** Absence of established and followed procedures to prevent microbiological contamination. This includes unvalidated aseptic processes, lack of controlled environments (e.g., no clean area control parameters), and deficient gowning procedures (only cap, mask, sterile gloves required, no gown). - **Sterility Testing:** Failure to perform sterility testing on approximately (b)(4) batches of SVF product (July 2015-July 2017) and (b)(4) batches of (b)(4) product (December 2015-July 2017). - **Environmental Monitoring:** No environmental monitoring (personnel, non-viable particulate, active/passive air) performed during manufacturing. - **Cleaning and Disinfection:** No written procedures for cleaning the manufacturing suite or reusable stainless steel instruments, lacking detail on methods, equipment, and materials. - **Component Identity Verification:** Failure to perform identity testing for components like (b)(4) used in SVF manufacturing. -