FDA 483 - BioXtek LLC - February 26, 2025

BioXtek LLC, a human tissue processor in Pompano Beach, FL, received a Form 483 with three observations. The inspection revealed significant issues including the manufacturing and distribution of amniotic membrane grafts without validated processes, failure to verify process changes, and inadequate testing of birth tissue donors for communicable disease agents like West Nile Virus. These findings indicate a lack of robust quality control and compliance with regulatory requirements for tissue processing.