NE Franklin News

There was one company in a city associated with Licking County that received FDA citations as a result of one inspection 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 50% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not.
• Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
• 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.

The company cited was involved in the Drugs 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
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