Elkhart Times

There were three companies in cities associated with Elkhart County that received FDA citations as a result of three inspections conducted in the county throughout 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 year.

Of the seven citations issued, the most common citation was 'Your extralabel use of an approved human or animal drug caused a residue above an established safe level, safe concentration, or tolerance'.

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

Of the companies cited, one should take voluntary action to correct its managing operations (33.3%). Additionally, two companies had to take regulatory and/or administrative actions (66.7%).

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
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
Marion Mullet Farm	Veterinary	06/22/2023	ELDU - producer causes Illegal drug residue
Marion Mullet Farm	Veterinary	06/22/2023	Record keeping
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