# FDA 483 - Re-Gen Active Lab Inc - July 28, 2021

Source: https://www.keypedia.com/records/483/re-gen-active-lab-inc/9af0a56c-d2aa-4e70-ba37-23da57d79b01

> FDA 483 for Re-Gen Active Lab Inc on July 28, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Re-Gen Active Lab Inc
- Inspection Date: 2021-07-28
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Re-Gen Active Lab Inc. in Irving, TX, a stem cell manufacturer, was cited for 11 significant violations during an FDA inspection. The firm failed to establish and follow critical procedures for aseptic processing, environmental monitoring, process validation, component control, cleaning, equipment control, batch records, donor eligibility, stability testing, and employee training. These deficiencies pose substantial risks to the sterility and quality of their injectable products derived from human umbilical cord tissue and amniotic membrane.

## Related Documents

- [483 - 2023-09-21](https://www.keypedia.com/records/483/re-gen-active-lab-inc/54d9f651-c59d-4746-82e3-149af8ce0bdd)

## Related Officers

- [Investigator](https://www.keypedia.com/people/abby-l-mozeke-baker/32e2896f-b836-4752-862e-de98370b8cad)
- [Decarlos A. Gomez](https://www.keypedia.com/people/decarlos-a-gomez/4b003235-edbb-4cb5-acb1-4e154941578c)

Company: https://www.keypedia.com/companies/re-gen-active-lab-inc/348e9f01-5a00-415d-9322-83f379a0e943

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