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

Source: https://www.keypedia.com/records/483/activeaid-medical-solutions-llc/24906948-1f25-4e5f-8603-16046b7d8fec

> FDA 483 for ActiveAID Medical Solutions LLC on August 18, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ActiveAID Medical Solutions LLC
- Inspection Date: 2023-08-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: 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.

## Related Officers

- [Laura E. Garcia](https://www.keypedia.com/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)

Company: https://www.keypedia.com/companies/activeaid-medical-solutions-llc/80a0427f-b2bf-446e-8b6c-42e2c15a5458

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6