North OC Times

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

This is a 33.3% increase over the number of companies cited in the previous month.

The citations in the county include:

• The written instructions in your master manufacturing record did not include instructions for corrective action plans to use when specifications are not met.
• You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance.
• You did not determine and document which verification activity or activities were needed to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Ari's Wholesale, LLC	Food and Cosmetics	05/15/2024	Evaluation - performance, risk
Ari's Wholesale, LLC	Food and Cosmetics	05/15/2024	Verification activity assurance
Ari's Wholesale, LLC	Food and Cosmetics	05/15/2024	Verification activity frequency
Ari's Wholesale, LLC	Food and Cosmetics	05/15/2024	Audit - food safety regulation, plan
Evoqua Water Technologies, LLC	Devices	05/14/2024	Label to bear a unique device identifier
Evoqua Water Technologies, LLC	Devices	05/14/2024	Quality Audits - defined intervals
Evoqua Water Technologies, LLC	Devices	05/14/2024	DHR content
Evoqua Water Technologies, LLC	Devices	05/14/2024	Devices subject to device identification GUDID data submission requirements.
Excelsior Nutrition, Inc.	Food and Cosmetics	05/23/2024	Corrective action plans
ProTab Laboratories	Food and Cosmetics	05/22/2024	Quality control - components, approve, release