FDA 483 - New Direction Biosciences LLC - June 12, 2015

An FDA inspection of IntelliCell BioSciences, Inc. in New York, NY, revealed significant deficiencies in the manufacturing of their Stromal Vascular Fraction (SVF) drug products. The firm failed to prevent microbiological contamination, lacked adequate production and process controls, and did not ensure the quality and purity of its products. These issues included unvalidated aseptic processes, equipment, and test methods, as well as the release of drug products without complete testing or proper quality assurance review, impacting patients receiving treatments for various medical conditions.