ActiveAID Medical Solutions LLCAugust 18, 2023

FDA 483 - ActiveAID Medical Solutions LLC - August 18, 2023

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ActiveAID Medical Solutions LLC, a human tissue warehouse in Sabana Grande, PR, was cited for multiple Current Good Tissue Practice (CGTP) deficiencies. The inspection revealed failures in recording and maintaining HCT/P storage temperatures, not following established procedures for handling and distribution, and lacking procedures for complaint review. Additionally, core CGTP procedures were not reviewed and approved by a responsible person before implementation.

Company: ActiveAID Medical Solutions LLC
Inspection Date: August 18, 2023
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East IV
Person: Laura E. Garcia

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ID · 24906948-1f25-4e5f-8603-16046b7d8fec