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Tuesday, December 3, 2024

How many companies in cities across Santa Cruz County received FDA citations in 2023?

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

There were nine companies in cities associated with Santa Cruz County that received FDA citations as a result of nine inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 52.6% decrease from the number of companies cited in the previous year.

Of the 15 citations issued, the most common citation was 'You did not develop an FSVP'.

All of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, eight should take voluntary actions to correct their managing operations (88.9%). Additionally, one company had to take regulatory and/or administrative actions (11.1%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Companies Located Within Santa Cruz County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Agricola Cactus, LLCFood and Cosmetics01/24/2023Develop FSVP
EHM Produce, LLC.Food and Cosmetics09/07/2023Develop FSVP
Frello Fresh, LLCFood and Cosmetics06/08/2023Develop FSVP
Frello Fresh, LLCFood and Cosmetics06/08/2023Hazard analysis biological, chemical, physical
Frello Fresh, LLCFood and Cosmetics06/08/2023Verification activity - appropriate
Jewel Marketing & Agribusiness a California LLC, LLCFood and Cosmetics04/25/2023Evaluation - performance, risk
Margot DistributingFood and Cosmetics06/28/2023Develop FSVP
R. P. Distributing Company, Inc.Food and Cosmetics03/13/2023Develop FSVP
Rene Produce, LLCFood and Cosmetics10/27/2023Evaluation - performance, risk
Rene Produce, LLCFood and Cosmetics10/27/2023Approved supplier procedures - importer established
Rene Produce, LLCFood and Cosmetics10/27/2023Supplier verification - establish written procedures
Rene Produce, LLCFood and Cosmetics10/27/2023Verification activity before import, periodically
Salvador Montoya, LLCFood and Cosmetics02/09/2023Develop FSVP
Tricar Sales, Inc.Food and Cosmetics06/01/2023Develop FSVP
Tricar Sales, Inc.Food and Cosmetics06/01/2023Record - translate to English

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