# FDA 483 - AVEM Labs LLC - November 22, 2022

Source: https://www.keypedia.com/records/483/avem-labs-llc/74e690cf-6a8f-4519-a585-f214dbeb2588

> FDA 483 for AVEM Labs LLC on November 22, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AVEM Labs LLC
- Inspection Date: 2022-11-22
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: AVEM LABS LLC, a stem cell manufacturer in Las Vegas, NV, was cited for multiple significant deficiencies during an FDA inspection from November 14-22, 2022. The observations primarily concern inadequate process validation, lack of stability data for expiration dates, insufficient aseptic process validation, poor record-keeping, and failures in donor eligibility determination and component control for their HCT/P products. These issues indicate a systemic lack of control over critical manufacturing and quality processes.

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## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [Eric T. Huebler](https://www.keypedia.com/people/eric-t-huebler/a3461591-1bf1-421c-9aef-e8271a2b8547)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6