Somerset Times

There was one company in a city associated with Somerset 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 unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

• Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
• Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
• Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that conform to appropriate standards of identity, strength, quality and purity.

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
Janssen Pharmaceuticals, Inc.	Biologics	12/14/2023	Training , Education , Experience overall
Janssen Pharmaceuticals, Inc.	Biologics	12/14/2023	Cleaning / Sanitizing / Maintenance
Janssen Pharmaceuticals, Inc.	Biologics	12/14/2023	Scientifically sound laboratory controls
Janssen Pharmaceuticals, Inc.	Biologics	12/14/2023	Who must report - manufacturer