# FDA 483 - AVEM Labs LLC - May 21, 2025

Source: https://www.keypedia.com/records/483/avem-labs-llc/84069ac4-49c1-4c70-9e6c-ca04ebadcff3

> FDA 483 for AVEM Labs LLC on May 21, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AVEM Labs LLC
- Inspection Date: 2025-05-21
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: AVEM Labs LLC in Las Vegas, NV, an HCT/P manufacturer, was inspected by the FDA from May 13-21, 2025. The inspection revealed significant deficiencies across multiple areas, including unvalidated manufacturing processes for amniotic membrane products, inadequate labeling procedures, uncalibrated temperature monitoring equipment, and a failure to maintain essential records for supplies and HCT/Ps. These observations indicate a lack of robust quality control and record-keeping practices.

## Related Documents

- [483 - 2022-11-22](https://www.keypedia.com/records/483/avem-labs-llc/74e690cf-6a8f-4519-a585-f214dbeb2588)

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [Garrad R. Poole](https://www.keypedia.com/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)

Company: https://www.keypedia.com/companies/avem-labs-llc/213cf700-de3e-4630-b4aa-81201ddc7c25

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df