FDA 483 - Amnion LLC - April 08, 2026

An FDA inspection of Amnion LLC, a human tissue processor in Sterling, VA, from March 24 to April 8, 2026, identified four significant observations. These included failures in timely environmental monitoring result reporting, lack of vendor certificates of analysis for incoming materials, inadequate documentation of facility cleaning, and non-concurrent batch record keeping. The findings indicate deficiencies in the firm's quality program and record management practices.