Portage Times

There was one company in a city associated with Portage County that received FDA citations as a result of one inspection 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:

• The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

The company cited should take a voluntary action to correct its 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
Natural Essentials Incorporated	Drugs	03/10/2023	Procedures not in writing, fully followed
Natural Essentials Incorporated	Drugs	03/10/2023	Equipment Design, Size and Location
Natural Essentials Incorporated	Drugs	03/10/2023	Investigations of discrepancies, failures