# FDA 483 - AUSTROFOOD S.A.S. - December 14, 2023

Source: https://www.globalkeysolutions.net/records/483/austrofood-sas/9cc4925c-fa95-41c7-b98f-0996437c10f1

> FDA 483 for AUSTROFOOD S.A.S. on December 14, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AUSTROFOOD S.A.S.
- Inspection Date: 2023-12-14
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: AUSTROFOOD S.A.S. in Quito, Ecuador, a human food manufacturer, received a Form 483 for significant deficiencies in its food safety plan and plant sanitation. Observations included a failure to identify heavy metal hazards in cinnamon, inadequate pasteurization monitoring, and a lack of preventive controls for physical hazards from damaged equipment. Additionally, the facility lacked proper backflow protection for water outlets.

## Related Documents

- [WARNING_LETTER - 2023-12-14](https://www.globalkeysolutions.net/records/warning_letter/austrofood-sas/4a789e08-1268-461d-a92a-b4e784a1da6d)

## Related Officers

- [Rovena Trevino-Solis](https://www.globalkeysolutions.net/people/rovena-trevino-solis/cf1af8f1-1555-4426-ae54-e5a80b65280a)
- [Israel Juabe](https://www.globalkeysolutions.net/people/israel-juabe/0722cfa0-325a-498d-8707-6a2563208a98)
- [Compliance Officer](https://www.globalkeysolutions.net/people/brant-m-schroeder/1da637d9-4db9-47d6-8382-9a38ea64c338)

Company: https://www.globalkeysolutions.net/companies/austrofood-sas/558c7cac-4ef2-41d1-8d49-f61d8bdf17a8

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