NE Franklin News

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

This is a 200% increase over the number of companies cited in the previous quarter.

Of the 10 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

All of the companies cited were involved in the Devices sector.

All of the companies cited should take voluntary actions to correct their 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
GFS Chemicals, Inc.	Devices	11/17/2023	Lack/Inad procedure-Monitoring/Control of Validated Proces
IncludeHealth	Devices	11/01/2023	Management review - Lack of or inadequate procedures
IncludeHealth	Devices	11/01/2023	Quality audits - Lack of or inadequate procedures
IncludeHealth	Devices	11/01/2023	Design validation - software validation not performed
IncludeHealth	Devices	11/01/2023	Lack of or inadequate procedures
IncludeHealth	Devices	11/01/2023	Lack of or inadequate complaint procedures
Vesco Medical, LLC	Devices	10/31/2023	Design control - no procedures
Vesco Medical, LLC	Devices	10/31/2023	Purchasing controls, Lack of or inadequate procedures
Vesco Medical, LLC	Devices	10/31/2023	Lack of or inadequate procedures
Vesco Medical, LLC	Devices	10/31/2023	Investigation of device failures