# FDA 483 - Unknown Company - October 24, 2018

Source: https://www.keypedia.com/records/483/unknown-company/9284922a-3d3c-417b-beac-ca13f6fdf964

> FDA 483 for Unknown Company on October 24, 2018. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Inspection Date: 2018-10-24
- Office Name: Office of Human and Animal Foods Operations - West 
- Summary: The U.S. Food & Drug Administration (FDA), in conjunction with the CDC, conducted an Environmental Assessment (EA) from June to August 2018, responding to a multi-state E. coli O157:H7 outbreak linked to romaine lettuce from the Yuma growing region of Arizona and California in early 2018. This assessment aimed to identify factors contributing to the contamination. During the investigation, the outbreak strain of E. coli O157:H7 was detected in three irrigation canal water samples along a 3.5-mile stretch in the Wellton area of Yuma County. This canal supplies water to several farms identified in the traceback investigation. Key contributing factors identified include the use of open irrigation canals drawing from the Colorado River for crop irrigation and diluting agricultural chemicals, the presence of a large Concentrated Animal Feeding Operation (CAFO) adjacent to the contaminated canal segment, and shallow groundwater potentially flowing from the CAFO towards unlined canal sections or being pumped directly into irrigation canals. A freeze event in February 2018, potentially damaging crops, and subsequent high winds were also considered. While this was an environmental assessment and not an inspection of a single company, the findings underscore critical vulnerabilities in agricultural water management and land use practices in the Yuma growing region. The regulatory framework involving FDA, CDC, and state agencies highlights the collective effort needed to address public health threats. The primary issue is the confirmed presence of the outbreak strain in agricultural water sources. These findings necessitate rigorous evaluation and implementation of robust water safety plans and land management strategies to prevent future contamination and protect public health, particularly within the leafy greens industry.

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## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Office: https://www.keypedia.com/offices/office-of-human-and-animal-foods-operations-west/7fb42cc5-a4fb-464a-8ec9-6db30f96d7c7