FDA 483 - StemGenex Biologic Laboratories, LLC - January 26, 2018

The FDA issued a Form 483 to StemGenex Biologic Laboratories, LLC following an inspection conducted from January 16-26, 2018, revealing significant deviations from current Good Manufacturing Practices (cGMPs) for a biological drug manufacturer. The inspection identified eleven observations, primarily centered on the firm's production of autologous, injectable Stromal Vascular Fraction (SVF) products. Major violations included the absence of validated manufacturing processes and aseptic processing procedures, resulting in numerous batches being produced without assurance of identity, strength, quality, or purity. The company also lacked adequate controls to prevent microbiological contamination, such as deficient gowning practices, insufficient environmental monitoring in aseptic areas, and a failure to conduct sterility testing on many SVF batches. Further issues highlighted inadequate laboratory controls, including the lack of established specifications for in-process materials and finished products, as well as unvalidated analytical methods. Supplier qualification for critical raw materials was found deficient, and identity testing for several components was not performed. The Quality Control Unit exhibited weaknesses, including unimplemented procedures, an insufficient system for adverse event detection and reporting, and inadequate staffing. Additionally, the firm lacked proper systems for handling drug product complaints and failed to provide cGMP training to its manufacturing personnel. StemGenex must address these deficiencies by validating its processes, implementing robust quality control and aseptic manufacturing practices, and establishing comprehensive complaint handling and employee training programs to achieve compliance with federal regulations.