FDA 483 - LifeLink Foundation, Inc. - July 15, 2022

Lifelink Foundation, Inc. in Tampa, FL, a human tissue establishment, was inspected from July 11-15, 2022. The inspection revealed that facilities were not maintained in a good state of repair, specifically citing a door system failure in the processing core that could lead to contamination or cross-contamination of human tissue. This indicates a potential risk to product integrity and safety.