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Thursday, November 7, 2024

FDA issued 10 citations in cities across Delaware County in Q4 2023

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

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.

Companies located within Delaware County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
GFS Chemicals, Inc.Devices11/17/2023Lack/Inad procedure-Monitoring/Control of Validated Proces
IncludeHealthDevices11/01/2023Management review - Lack of or inadequate procedures
IncludeHealthDevices11/01/2023Quality audits - Lack of or inadequate procedures
IncludeHealthDevices11/01/2023Design validation - software validation not performed
IncludeHealthDevices11/01/2023Lack of or inadequate procedures
IncludeHealthDevices11/01/2023Lack of or inadequate complaint procedures
Vesco Medical, LLCDevices10/31/2023Design control - no procedures
Vesco Medical, LLCDevices10/31/2023Purchasing controls, Lack of or inadequate procedures
Vesco Medical, LLCDevices10/31/2023Lack of or inadequate procedures
Vesco Medical, LLCDevices10/31/2023Investigation of device failures

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