Union County Review

There was one company in a city associated with Union County that received FDA citations as a result of one inspection conducted in the county over the third quarter of 2024, 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 quarter.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and 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.
• Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

The company cited was involved in the Drugs sector.

The company cited had to take regulatory and/or administrative actions.

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
Health Pharma USA, LLC	Drugs	07/03/2024	Procedures not in writing, fully followed
Health Pharma USA, LLC	Drugs	07/03/2024	Equipment Design, Size and Location
Health Pharma USA, LLC	Drugs	07/03/2024	Written procedures not established/followed
Health Pharma USA, LLC	Drugs	07/03/2024	Computer control of master formula records
Health Pharma USA, LLC	Drugs	07/03/2024	Absence of Written Procedures
Health Pharma USA, LLC	Drugs	07/03/2024	Scientifically sound laboratory controls
Health Pharma USA, LLC	Drugs	07/03/2024	Valid stability test methods