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

An FDA inspection of Minaris Regenerative Medicine, LLC in Allendale, NJ, a contract manufacturer, revealed significant deficiencies in their quality systems. Observations included a failure to establish adequate written procedures for production and process controls, particularly regarding deviation documentation for LYFGENIA. Additionally, the firm lacked written procedures for handling post-marketing adverse drug experiences and failed to document major equipment in batch production records.