NE Franklin News

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

This is a 46.2% decrease from the number of companies cited in the previous year.

Of the 26 citations issued, the most common citations were 'A qualified container closure inspection person did not record the observations made of the top seam of a can randomly selected from each seaming head and the container closures at intervals of sufficient frequency to ensure proper closure' and 'Procedures for corrective and preventive action have not been adequately established'.

Most of the companies cited were involved in either Devices or Food and Cosmetics sectors.

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
Big Lots, Inc.	Food and Cosmetics	03/22/2023	LACF compliance
Big Lots, Inc.	Food and Cosmetics	03/22/2023	Hazard analysis written
Big Lots, Inc.	Food and Cosmetics	03/22/2023	Supplier verification - establish written procedures
Big Lots, Inc.	Food and Cosmetics	03/22/2023	Verification activity frequency
Dan the Baker, LLC	Food and Cosmetics	03/01/2023	Personnel
Dan the Baker, LLC	Food and Cosmetics	03/01/2023	Plant construction and design
Dan the Baker, LLC	Food and Cosmetics	03/01/2023	Sanitary facilities and controls
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
Mars Petcare US, Inc.	Food and Cosmetics	01/23/2023	Frequency: visual closure examinations, record
Mars Petcare US, Inc.	Veterinary	01/23/2023	Frequency: visual closure examinations, record
Safecor Health, LLC	Drugs	09/01/2023	Identity Testing of Each Component
Safecor Health, LLC	Drugs	09/01/2023	Absence of Written Procedures
Safecor Health, LLC	Drugs	09/01/2023	Changes to Procedures Not Reviewed, Approved
Safecor Health, LLC	Drugs	09/01/2023	Reprocessing/quality control unit
Safecor Health, LLC	Drugs	09/01/2023	Sample size - test intervals
Safecor Health, LLC	Drugs	09/01/2023	Written records kept in individual logs
Safecor Health, LLC	Drugs	09/01/2023	Investigations of discrepancies, failures
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