South Franklin News

There were 12 companies in cities associated with Franklin County that received FDA citations as a result of 12 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% decrease from the number of companies cited in the previous year.

Of the 42 citations issued, the most common citations include:

• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
• Your plant was not constructed and designed to facilitate maintenance and sanitary operations.
• The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the 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
AVT Technologies, LLC.	Devices	04/20/2023	Lack of or inadequate complaint procedures
AVT Technologies, LLC.	Devices	04/20/2023	Servicing - Lack of or inadequate procedures
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
James & James	Food and Cosmetics	03/27/2023	Develop FSVP
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
ODW Logistics, Inc.	Food and Cosmetics	02/16/2023	Plant construction and design
ODW Logistics, Inc.	Food and Cosmetics	02/16/2023	Pest control
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
Shasta Beverages, Inc.	Food and Cosmetics	07/13/2023	Sanitary operations - Plant maintenance
Shasta Beverages, Inc.	Food and Cosmetics	07/13/2023	Sanitation of non-food-contact surfaces - Manner and frequency
Tri Technician Laboratories, LLC	Drugs	12/19/2023	Procedures not in writing, fully followed
Tri Technician Laboratories, LLC	Drugs	12/19/2023	Computer control of master formula records
Tri Technician Laboratories, LLC	Drugs	12/19/2023	Identity Testing of Each Component
Tri Technician Laboratories, LLC	Drugs	12/19/2023	Reports of Analysis (Components)
Tri Technician Laboratories, LLC	Drugs	12/19/2023	Establishment of time limitations
Tri Technician Laboratories, LLC	Drugs	12/19/2023	Scientifically sound laboratory controls
Tri Technician Laboratories, LLC	Drugs	12/19/2023	Test methods
Tri Technician Laboratories, LLC	Drugs	12/19/2023	Valid stability test methods
Tri Technician Laboratories, LLC	Drugs	12/19/2023	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