# FDA 483 - Biograft Transplant Services Inc - August 27, 2021

Source: https://www.keypedia.com/records/483/biograft-transplant-services-inc/7c9a3595-838a-4b86-bc7c-27aea562d822

> FDA 483 for Biograft Transplant Services Inc on August 27, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biograft Transplant Services Inc
- Inspection Date: 2021-08-27
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Biograft Transplant Services Inc in Houston, TX, a human tissue establishment, revealed significant deficiencies in environmental monitoring and control within their recovery suite. The firm failed to monitor for microorganisms, control humidity, and maintain documentation for temperature control, raising concerns about potential contamination of human cells, tissues, and cellular and tissue-based products (HCT/Ps). These issues suggest a lack of adequate controls to prevent contamination and ensure product safety.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/jennifer-a-kemp/51aa8f2f-ba64-47d3-aa06-b4595b3d15c8)
- [Investigator](https://www.keypedia.com/people/darla-j-christopher/64d3f47f-f3c0-4cfd-a3e8-4dc0e69d04bd)

Company: https://www.keypedia.com/companies/biograft-transplant-services-inc/fab992db-4029-46e2-bc21-acb4fe75c65c

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