LifeLink Foundation, Inc.July 15, 2022

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

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Record Details

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.

Company: LifeLink Foundation, Inc.
Inspection Date: July 15, 2022
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
People: Lara D Baquero
Barbara T. Carmichael (Investigator at U.S.FDA)
Johnathan M Crayton

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ID · f7fd6c04-dc40-41ba-9319-5ef0d7d3bedc