FDA 483 - Ascension Biologics LLC - September 19, 2025

Ascension Biologics LLC, a tissue storage and distribution facility in Austin, TX, was cited for failing to record and maintain storage temperatures for HCT/Ps. This critical lapse occurred during a company relocation and due to a power failure, impacting a significant inventory of amniotic membrane and dermal tissues. The observations indicate serious deficiencies in environmental control and record-keeping for sensitive biological products.