# FDA 483 - CANELS USA LLC                12 - April 14, 2025

Source: https://www.globalkeysolutions.net/records/483/canels-usa-llc-12/8006c883-7eb0-40af-b076-56a6be272804

> FDA 483 for CANELS USA LLC                12 on April 14, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CANELS USA LLC                12
- Inspection Date: 2025-04-14
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of CANEL'S USA, LLC in Houston, TX, revealed a significant deficiency in their Foreign Supplier Verification Program (FSVP). The firm failed to document their review and assessment of hazard analyses conducted by foreign suppliers, specifically for imported candies. Additionally, they lacked documentation confirming that these hazard analyses were performed by qualified individuals, indicating a critical gap in ensuring the safety of their imported products.

## Related Officers

- [Terris A. Mackey](https://www.globalkeysolutions.net/people/terris-a-mackey/c4e73695-1feb-4827-895e-6ac914b15fc4)

Company: https://www.globalkeysolutions.net/companies/canels-usa-llc-12/a57fd244-4c64-4096-be61-dd95991b0ac7

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9