# FDA 483 - LifeGift Organ Donation Center - Fort Worth - August 06, 2021

Source: https://www.keypedia.com/records/483/lifegift-organ-donation-center-fort-worth/3b99e97d-a301-4162-8043-2da8baadd77a

> FDA 483 for LifeGift Organ Donation Center - Fort Worth on August 06, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LifeGift Organ Donation Center - Fort Worth
- Inspection Date: 2021-08-06
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of LifeGift Organ Donation Center - Fort Worth revealed significant deficiencies in environmental monitoring and quality program procedures for human tissue recovery. The facility failed to monitor environmental conditions in its tissue recovery suite, leading to potential contamination of HCT/Ps. Additionally, the firm lacked established procedures for core Current Good Tissue Practices (CGTP) requirements and did not effectively investigate or implement corrective actions for numerous humidity excursions.

## Related Officers

- [Elmina E Akwo](https://www.keypedia.com/people/elmina-e-akwo/ecd9066d-1647-4765-ad86-dbe5280241c5)

Company: https://www.keypedia.com/companies/lifegift-organ-donation-center-fort-worth/a90e5857-def2-4e9b-ae98-3f05ffa8d1a2

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