FDA 483 - Re-Gen Active Lab Inc - September 21, 2023

Re-Gen Active Lab Inc. in Irving, TX, was inspected regarding its HCTP/Biological Drug manufacturing. The inspection revealed severe and repeated deficiencies across multiple critical areas, including a lack of validation for sterilization and aseptic processes, inadequate environmental monitoring, poor equipment maintenance and calibration, unvalidated sterility testing, and insufficient quality control and record-keeping practices. These issues raise significant concerns about the sterility, identity, strength, purity, and quality of their purported sterile drug products.