South Jersey Sun

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

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been established.
• Procedures for device history records have not been adequately established.
• You did not establish procedures for holding and distributing operations.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%).

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
Bahadir USA, LLC	Devices	07/17/2023	Process control procedures, Lack of or inadequate procedures
Bahadir USA, LLC	Devices	07/17/2023	Lack of or inadequate DHR procedures
Sterigenics US, LLC	Devices	05/31/2023	Lack of or inadequate process validation
Sterigenics US, LLC	Devices	05/31/2023	Lack of or inadequate procedures
Sterigenics US, LLC	Devices	05/31/2023	DHR content
Trek Bicycle	Food and Cosmetics	07/06/2023	Written procedures - holding