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The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
FDA sent a warning letter, dated Oct. 31, 2018, to StemGenex Biologic Laboratories, LLC after an agency inspection of the company’s San Diego, CA facility found deviations from current good manufacturing practices. The agency also warned that the company was marketing a purported stem cell product without FDA approval.
Inspectors discovered that the company was processing adipose tissue into stromal vascular fraction (SVF) for administration intravenously, by inhalation, or directly into the spinal canal to ‘treat’ serious diseases including Alzheimer’s disease, Crohn’s disease, Type I and Type II diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, peripheral neuropathy, and rheumatoid arthritis.
According to a statement by FDA, “StemGenex’s SVF product, which involves more than minimal manipulation of a patient’s adipose tissue, is regulated as both a drug and biological product. To lawfully market its SVF product, a valid biologics license must be in effect. While in the development stage, the firm’s SVF product may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or approvals exist for StemGenex’s product, and the firm does not have an IND in effect.”
CGMP violations found at the facility during the FDA inspection include unvalidated manufacturing processes, uncontrolled environment, lack of control of components used in production, and lack of sufficient and validated product testing (sterility and endotoxin testing). The agency stated in a warning letter that these violations “pose a significant risk that your SVF product may be contaminated with microorganisms or have other serious product quality defects.” Additional violations included failure to establish written procedures to prevent microbiological contamination, failure to perform media fill simulations, inappropriate gowning, failure to perform laboratory testing, failure to establish defined areas of operations, failure to perform environmental monitoring, failure to maintain laboratory controls, and failure to establish a quality control unit, among others.