FDA: 4 companies in cities within Kosciusko County received 9 citations in 2023

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

By Elkhart Times

Oct 28, 2024

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

This is an increase over the number of companies cited in the previous year.

Of the nine citations issued, the most common citation was 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established'.

Most of the companies cited were involved in the Devices sector.

Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).

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.

Companies Located Within Kosciusko County Cities and the Citations They Received in 2023

Company Name	Area of Business	Inspection Date	Issue Cited
Jatex, Inc.	Devices	06/15/2023	Process control procedures, Lack of or inadequate procedures
Jatex, Inc.	Devices	06/15/2023	Lack of or inadequate complaint procedures
Martin Farm - Konrad Martin	Veterinary	06/21/2023	ELDU - producer causes Illegal drug residue
Martin Farm - Konrad Martin	Veterinary	06/21/2023	Drugs prohibited for extralabel use in food-producing animal(s)
Martin Farm - Konrad Martin	Veterinary	06/21/2023	Record keeping
NG Instruments, Inc.	Devices	12/14/2023	Lack of or inadequate process validation
NG Instruments, Inc.	Devices	12/14/2023	Lack of or inadequate In-process acceptance procedures
NG Instruments, Inc.	Devices	12/14/2023	Nonconforming product, Lack of or inadequate procedures
OrthoPediatrics Corporation	Devices	08/18/2023	Lack of or inadequate complaint procedures