FDA 483 - American Cell Technology, LLC. - October 29, 2021

American Cell Technology, LLC in Sunrise, FL, a manufacturer of adipose-derived cellular products, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across multiple areas, including inadequate validation of aseptic processes, lack of written procedures for production controls, insufficient environmental monitoring, and unvalidated sterility test methods. Additionally, the firm lacked proper record-keeping for equipment maintenance, quality control unit procedures and training, and written procedures for labeling and packaging materials.