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North OC Times

Thursday, November 21, 2024

FDA: 8 companies in cities within Orange County received 15 citations in Q2

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

There were eight companies in cities associated with Orange County that received FDA citations as a result of eight inspections conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 60% increase over the number of companies cited in the previous quarter.

Of the 15 citations issued, the most common citation was 'An onsite audit of a foreign supplier did not consider an applicable food safety regulation'.

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

All of the companies cited should take voluntary actions to correct their managing operations.

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 Orange County Cities and the citations they received in Q2
Company NameArea of BusinessInspection DateIssue Cited
Ari's Wholesale, LLCFood and Cosmetics05/15/2024Evaluation - performance, risk
Ari's Wholesale, LLCFood and Cosmetics05/15/2024Verification activity assurance
Ari's Wholesale, LLCFood and Cosmetics05/15/2024Verification activity frequency
Ari's Wholesale, LLCFood and Cosmetics05/15/2024Audit - food safety regulation, plan
Evoqua Water Technologies, LLCDevices05/14/2024Label to bear a unique device identifier
Evoqua Water Technologies, LLCDevices05/14/2024Quality Audits - defined intervals
Evoqua Water Technologies, LLCDevices05/14/2024DHR content
Evoqua Water Technologies, LLCDevices05/14/2024Devices subject to device identification GUDID data submission requirements.
Excelsior Nutrition, Inc.Food and Cosmetics05/23/2024Corrective action plans
Harris Spice Company, Inc.Food and Cosmetics04/19/2024Personnel
Interfresh, Inc.Food and Cosmetics04/30/2024Evaluation - performance, risk
Interfresh, Inc.Food and Cosmetics04/30/2024Audit - food safety regulation, plan
National Medical Products, Inc.Devices05/30/2024Lack of or inadequate procedures
ProTab LaboratoriesFood and Cosmetics05/22/2024Quality control - components, approve, release
St. Tea/Good Won Foods, LLCFood and Cosmetics04/18/2024Develop FSVP

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