Union News

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 second 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:

• No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
• A quality plan has not been established.
• Procedures for quality audits have not been established.

The company cited was involved in the Devices sector.

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
General Hospital Supply Corporation	Devices	04/03/2024	Management representative
General Hospital Supply Corporation	Devices	04/03/2024	Quality plan
General Hospital Supply Corporation	Devices	04/03/2024	Quality audits - Lack of or inadequate procedures
General Hospital Supply Corporation	Devices	04/03/2024	Design control - no procedures
General Hospital Supply Corporation	Devices	04/03/2024	Lack of or inadequate procedures
General Hospital Supply Corporation	Devices	04/03/2024	Lack of or inadequate procedures for labeling
General Hospital Supply Corporation	Devices	04/03/2024	Control number {see also 820.65, 820.184(f)}
General Hospital Supply Corporation	Devices	04/03/2024	Records of complaint investigation - UDI
General Hospital Supply Corporation	Devices	04/03/2024	Statistical techniques - Lack of or inadequate procedures