Warren-Clinton News

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

This is unchanged from the number of companies cited in the previous year.

The citations in the county include:

• Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period.
• You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.
• You did not follow written procedures for quality control operations.

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

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Kraft Heinz Company	Food and Cosmetics	09/01/2023	Code - required elements
Source-Omega, LLC	Food and Cosmetics	01/19/2023	Specifications - contamination limits
Source-Omega, LLC	Food and Cosmetics	01/19/2023	Written procedures - quality control operations
Source-Omega, LLC	Food and Cosmetics	01/19/2023	Quality control - reserve samples
Source-Omega, LLC	Food and Cosmetics	01/19/2023	Master manufacturing record - unique formulation
Source-Omega, LLC	Food and Cosmetics	01/19/2023	Batch record - every batch
Source-Omega, LLC	Food and Cosmetics	01/19/2023	Written procedures - labeling operations
Source-Omega, LLC	Food and Cosmetics	01/19/2023	Written procedures - holding