# FDA 483 - Alon Medical Technology, LLC - March 31, 2022

Source: https://www.keypedia.com/records/483/alon-medical-technology-llc/065d5d69-9d8a-46e0-bc0a-f8fb64dfbe81

> FDA 483 for Alon Medical Technology, LLC on March 31, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alon Medical Technology, LLC
- Inspection Date: 2022-03-31
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: Alon Medical Technology, LLC, a tissue distributor in Lafayette, LA, was cited for significant deficiencies in record-keeping during an FDA inspection. Observations included a lack of documentation for incoming human cells, tissues, and cellular and tissue-based products (HCT/Ps) inspections and inconsistent, incomplete, and inaccurate temperature logs for stored tissue products. These issues indicate a failure to maintain adequate control over critical processes and environmental conditions.

## Related Officers

- [Fabian N. Chaparro-rodriguez](https://www.keypedia.com/people/fabian-n-chaparro-rodriguez/f14fd931-0830-4a84-a287-2dd85e40195d)

Company: https://www.keypedia.com/companies/alon-medical-technology-llc/77aa0346-2945-4eba-924b-1899f9031fed

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