# FDA 483 - Ascension Biologics LLC - September 19, 2025

Source: https://www.keypedia.com/records/483/ascension-biologics-llc/1c977ec2-778e-4baa-a9e6-fbdfaade98e2

> FDA 483 for Ascension Biologics LLC on September 19, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascension Biologics LLC
- Inspection Date: 2025-09-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [Michelle Paxon](https://www.keypedia.com/people/michelle-paxon/1748c593-7d85-4ede-a5f4-8c0a33c21d52)

Company: https://www.keypedia.com/companies/ascension-biologics-llc/c15d694b-ee98-42b0-8620-3ff3c9eb0db0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab