FDA 483 - EUCYT Laboratories LLC - November 21, 2019

An FDA inspection of EuCyt Laboratories LLC in Las Vegas, NV, a stem cell manufacturer, revealed numerous critical deficiencies. The firm failed to ensure donor eligibility, lacked adequate aseptic processing validation and controls, and did not properly investigate sterility failures. Significant issues were also noted in environmental monitoring, product stability data, complaint handling, and batch record documentation, indicating a severe lack of quality control for their HCT/P products.