# FDA 483 - Re-Gen Active Lab Inc - September 21, 2023

Source: https://www.keypedia.com/records/483/re-gen-active-lab-inc/54d9f651-c59d-4746-82e3-149af8ce0bdd

> FDA 483 for Re-Gen Active Lab Inc on September 21, 2023. 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: 2023-09-21
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Re-Gen Active Lab Inc. in Irving, TX, was inspected regarding its HCTP/Biological Drug manufacturing. The inspection revealed severe and repeated deficiencies across multiple critical areas, including a lack of validation for sterilization and aseptic processes, inadequate environmental monitoring, poor equipment maintenance and calibration, unvalidated sterility testing, and insufficient quality control and record-keeping practices. These issues raise significant concerns about the sterility, identity, strength, purity, and quality of their purported sterile drug products.

## Related Documents

- [483 - 2021-07-28](https://www.keypedia.com/records/483/re-gen-active-lab-inc/9af0a56c-d2aa-4e70-ba37-23da57d79b01)

## Related Officers

- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)
- [William F. Lagud](https://www.keypedia.com/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)

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