FDA 483 - SURGENEX LLC - April 16, 2021

SURGENEX LLC received a Form 483 for significant deficiencies in their manufacturing of aseptically processed injectable products derived from human umbilical cord and amniotic membrane, as well as HCT/Ps. Key issues include inadequate environmental monitoring, lack of aseptic process validation, failure to investigate sterility failures and customer complaints, and deficiencies in process validation, production controls, and equipment maintenance. These observations indicate a systemic lack of control over critical manufacturing processes impacting product sterility and quality.