483
ActiveAID Medical Solutions LLCActiveAID Medical Solutions LLC – FDA 483, Aug 18, 2023
Record Details
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.
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ID · 24906948-1f25-4e5f-8603-16046b7d8fec
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