FDA 483 - Age Management Institute Santa Barbara - April 12, 2021

An FDA inspection of Age Management Institute Santa Barbara revealed critical deficiencies in the production of purportedly sterile drug products for IV therapy. The firm lacked proper environmental controls, including HEPA filtration, and exhibited widespread non-microbial contamination in its sterile processing areas. Additionally, the facility failed to use appropriate sporicidal agents and utilized expired components in the manufacturing of sterile drug products, raising significant concerns about product quality and patient safety.