483
Ascension Biologics LLCAscension Biologics LLC – FDA 483, Sep 19, 2025
Record Details
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.
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ID · 1c977ec2-778e-4baa-a9e6-fbdfaade98e2
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