FDA 483 - Minaris Regenerative Medicine, LLC

An FDA inspection of Minaris Regenerative Medicine LLC in Allendale, NJ, identified multiple failures to adhere to written standard operating procedures during production, particularly in aseptic operations. These deficiencies included improper cleanroom practices, incorrect handling of cellular source material, unsafe needle capping techniques, and neglected post-use procedures for a controlled rate freezer. The findings indicate a significant lack of compliance with established protocols, which could impact product quality and safety.