# FDA 483 - Alon Medical Technology - March 08, 2022

Source: https://www.globalkeysolutions.net/records/483/alon-medical-technology/51643d31-db94-4f23-bef5-37c8efa25137

> FDA 483 for Alon Medical Technology on March 08, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alon Medical Technology
- Inspection Date: 2022-03-08
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: Alon Medical Technology in Metairie, LA, a tissue distributor, received a Form 483 with five observations primarily related to inadequate documentation and procedural controls for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed issues with unverified procedures, lack of review and approval for core procedures, insufficient documentation of corrective actions for storage conditions, incomplete HCT/P receipt records, and absence of facility cleaning records. These findings indicate significant deficiencies in the firm's quality system and adherence to current good tissue practices (CGTP).

## Related Officers

- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/edward-a-brunt/f823f6cb-7fb1-422b-b022-cb0d673f6210)
- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.globalkeysolutions.net/companies/alon-medical-technology/09ad6bce-fe18-4b64-8662-0e527b5b088a

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