# FDA 483 - SURGENEX LLC - March 29, 2023

Source: https://www.keypedia.com/records/483/surgenex-llc/ef3ad5e9-43d0-4898-9884-ea211280ab1c

> FDA 483 for SURGENEX LLC on March 29, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SURGENEX LLC
- Inspection Date: 2023-03-29
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of SURGENEX LLC in Scottsdale, AZ, from March 22-29, 2023, revealed a significant issue with quality control. The firm failed to adequately control in-process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and did not ensure sterilization validation requirements were met before product release. This included a failure to process dose audit samples and a delay in opening a deviation report.

## Related Documents

- [483 - 2021-04-16](https://www.keypedia.com/records/483/surgenex-llc/e831c76b-a1b5-42bf-aaa5-26c30876c5b2)
- [WARNING_LETTER - 2021-04-16](https://www.keypedia.com/records/warning_letter/surgenex-llc/65d6300a-6e48-46a3-b4f9-8db8e28055e3)

## Related Officers

- [investigator](https://www.keypedia.com/people/kaarin-m-slotte/2960bbe1-17ba-4295-9aa8-2514a1595336)
- [Garrad R. Poole](https://www.keypedia.com/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)

Company: https://www.keypedia.com/companies/surgenex-llc/7577df14-aa69-4670-89bf-a4e3f4f8d691

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