Somerset Times

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

This is a 20% increase over the number of companies cited in the previous year.

Of the 36 citations issued, the most common citations include:

• Document control procedures have not been adequately established.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
• Procedures for corrective and preventive action have not been adequately established.

Most of the companies cited were involved in either Biologics or Devices 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
Italian Products USA, Inc.	Food and Cosmetics	06/28/2023	Hazard analysis biological, chemical, physical
Italian Products USA, Inc.	Food and Cosmetics	06/28/2023	Evaluation - performance, risk
Italian Products USA, Inc.	Food and Cosmetics	06/28/2023	Verification activity frequency
Italian Products USA, Inc.	Food and Cosmetics	06/28/2023	Record - translate to English
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
Light Age, Inc.	Devices	09/29/2023	Lack of or inadequate organizational structure
Light Age, Inc.	Devices	09/29/2023	Management review - defined interval, sufficient frequency
Light Age, Inc.	Devices	09/29/2023	Training - Lack of or inadequate procedures
Light Age, Inc.	Devices	09/29/2023	Design history file
Light Age, Inc.	Devices	09/29/2023	Procedures not adequately established or maintained
Light Age, Inc.	Devices	09/29/2023	Purchasing controls, Lack of or inadequate procedures
Light Age, Inc.	Devices	09/29/2023	Evaluation of suppliers, contractors, etc., requirements
Light Age, Inc.	Devices	09/29/2023	Calibration procedures - content
Light Age, Inc.	Devices	09/29/2023	Remedial action
Light Age, Inc.	Devices	09/29/2023	Nonconforming product, Lack of or inadequate procedures
Light Age, Inc.	Devices	09/29/2023	Lack of or inadequate procedures
Light Age, Inc.	Devices	09/29/2023	DMR - not or inadequately maintained
Light Age, Inc.	Devices	09/29/2023	DHR - not or inadequately maintained
Light Age, Inc.	Devices	09/29/2023	Complaints
Manara, Dr Louis R	Biologics	05/23/2023	Donors with risks not determined ineligible
Micro Stamping Corporation	Devices	01/18/2023	Procedures not adequately established or maintained
Micro Stamping Corporation	Devices	01/18/2023	Purchasing controls, Lack of or inadequate procedures
Micro Stamping Corporation	Devices	01/18/2023	Environmental control Lack of or inadequate procedures
Micro Stamping Corporation	Devices	01/18/2023	Product rework procedures, Lack of or inadequate procedures
Micro Stamping Corporation	Devices	01/18/2023	Lack of or inadequate procedures
SOFIE Company	Drugs	01/20/2023	Determination need for investigation
SOFIE Company	Drugs	01/20/2023	Written QA procedures established, followed
SOFIE Company	Drugs	01/20/2023	Equipment procedures
SOFIE Company	Drugs	01/20/2023	Adequate controls (general)
SOFIE Company	Drugs	01/20/2023	Equipment
SOFIE Company	Drugs	01/20/2023	Before implementing new procedure establish and document accuracy etc.
SOFIE Company	Drugs	01/20/2023	Correction of problems
SOFIE Company	Drugs	01/20/2023	Written complaint procedures