FDA 483 - Minaris Regenerative Medicine, LLC - September 29, 2025

An FDA inspection of Minaris Regenerative Medicine, LLC in Allendale, NJ, a contract manufacturer of gene therapy drugs, identified three significant observations. The firm failed to establish adequate written procedures for production and process controls, particularly regarding deviation documentation for LYFGENIA manufacturing. Additionally, there were no written procedures for handling post-marketing adverse drug experiences for their product, lovo-cel (LYFGENIA), and batch records lacked documentation of major equipment used in production.