Morris Leader

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

This is a 700% increase over the number of companies cited in the previous year.

Of the 22 citations issued, the most common citations were 'A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures' and 'Procedures for corrective and preventive action have not been adequately established'.

Most of the companies cited were involved in either Devices or Drugs 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
Addivation Medical	Devices	01/12/2023	Design changes - Lack of or Inadequate Procedures
Addivation Medical	Devices	01/12/2023	Purchasing controls, Lack of or inadequate procedures
Addivation Medical	Devices	01/12/2023	Lack of or inadequate process validation
Addivation Medical	Devices	01/12/2023	Lack/Inad procedure-Monitoring/Control of Validated Proces
Addivation Medical	Devices	01/12/2023	Lack of or inadequate procedures for labeling
Addivation Medical	Devices	01/12/2023	DMR - not or inadequately maintained
Airgas USA, LLC	Drugs	06/21/2023	Distinctive ID or code not recorded in batch record
Airgas USA, LLC	Drugs	06/21/2023	Complete Test Data
Airgas USA, LLC	Drugs	06/21/2023	Procedures to be written and followed
Dimensional Merchandising, Inc.	Drugs	04/18/2023	Written procedures not established/followed
Dimensional Merchandising, Inc.	Drugs	04/18/2023	Computer control of master formula records
Dimensional Merchandising, Inc.	Drugs	04/18/2023	Identity Testing of Each Component
Dimensional Merchandising, Inc.	Drugs	04/18/2023	Annual visual exams of drug products
Life Recovery Systems HD, LLC	Devices	09/11/2023	Nonconforming product, Lack of or inadequate procedures
Life Recovery Systems HD, LLC	Devices	09/11/2023	Lack of or inadequate procedures
Novartis Pharmaceuticals Corporation	Drugs	08/21/2023	General responsibilities of sponsors
Shriji Marketing, Inc.	Food and Cosmetics	01/30/2023	Develop FSVP
Sterigenics U. S., LLC	Devices	08/15/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Sterigenics U. S., LLC	Devices	08/15/2023	Remedial action
Sterigenics U. S., LLC	Devices	08/15/2023	Lack of or inadequate process validation
Sterigenics U. S., LLC	Devices	08/15/2023	Lack of or inadequate procedures
Tnuva USA, Inc.	Food and Cosmetics	04/20/2023	Hazard analysis biological, chemical, physical