# FDA 483 - Thuan Thien Producing Trading Limited Company - September 08, 2023

Source: https://www.keypedia.com/records/483/thuan-thien-producing-trading-limited-company/eb52ecf2-8361-4c7f-bc95-fcd978f02b97

> FDA 483 for Thuan Thien Producing Trading Limited Company on September 08, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thuan Thien Producing Trading Limited Company
- Inspection Date: 2023-09-08
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: Thuan Thien Producing Trading Limited Company, a manufacturer of frozen juices in Long An City, Vietnam, was cited for significant deficiencies related to pathogen reduction processes and their HACCP plans. The firm failed to conduct a 5-log pathogen reduction process on its juices within its facility and lacked validation data for off-site treatments. Additionally, their HACCP plans did not include necessary control measures to achieve the required 5-log reduction.

## Related Documents

- [WARNING_LETTER - 2023-09-08](https://www.keypedia.com/records/warning_letter/thuan-thien-producing-trading-limited-company/c43fe081-38e2-4ac6-ac9e-bd9f9c6b1799)

## Related Officers

- [investigator](https://www.keypedia.com/people/robert-w-calais/394ed883-caf9-43d2-9dd2-dab1d14f1a00)

Company: https://www.keypedia.com/companies/thuan-thien-producing-trading-limited-company/e1643941-3874-4007-8b85-72a66ad6e628

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1