# FDA 483 - Alon Medical Technology - October 16, 2024

Source: https://www.keypedia.com/records/483/alon-medical-technology/cbef4b00-9f15-4370-9ca0-0540299c88c9

> FDA 483 for Alon Medical Technology on October 16, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alon Medical Technology
- Inspection Date: 2024-10-16
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Alon Medical Technology in Flowood, MS, an HCT/P distributor, revealed significant deficiencies in their quality system. Observations included a lack of documented review and approval for core CGTP procedures, failure to follow HCT/P receipt procedures, and the absence of periodic quality audits. Additionally, the firm failed to maintain proper documentation for facility cleaning and sanitation activities.

## Related Officers

- [Juanelma H. Palmer](https://www.keypedia.com/people/juanelma-h-palmer/db3e79b5-d2d4-46d8-a075-4674dbc8c3d0)

Company: https://www.keypedia.com/companies/alon-medical-technology/7dd6cd04-e959-42f0-bfa8-37081225894d

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea