# FDA 483 - StemGenex Biologic Laboratories, LLC - January 26, 2018

Source: https://www.globalkeysolutions.net/records/483/stemgenex-biologic-laboratories-llc/c7902a88-c981-408e-992f-6693cf64577c

> FDA 483 for StemGenex Biologic Laboratories, LLC on January 26, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: StemGenex Biologic Laboratories, LLC
- Inspection Date: 2018-01-26
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of StemGenex Biologic Laboratories, LLC in San Diego, CA, revealed significant deficiencies in the manufacturing of their autologous, injectable Stromal Vascular Fraction (SVF) product. The firm failed to validate manufacturing and aseptic processes, lacked environmental monitoring, and had inadequate laboratory controls and quality unit oversight. These serious issues indicate a systemic failure to adhere to current Good Manufacturing Practices, potentially compromising product quality and patient safety.

## Related Documents

- [483 - 2018-01-26](https://www.globalkeysolutions.net/records/483/stemgenex-biologic-laboratories-llc/7e4c21ee-995e-4b93-8b68-575c8a3d40d3)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/yvonne-c-wilkes/44e7b094-d09a-48f0-a0ee-f1a6506f935a)
- [Colleen Aspinwall](https://www.globalkeysolutions.net/people/colleen-aspinwall/d3c98644-e796-4a7f-82d0-9c49e93c0940)
- [National Expert, Pharmaceutical](https://www.globalkeysolutions.net/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

Company: https://www.globalkeysolutions.net/companies/stemgenex-biologic-laboratories-llc/047276e3-17d7-4742-9dae-2e1fc4b49724

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