South Bend Times

There were three companies in a city associated with St. Joseph County that received FDA citations as a result of three inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 40% decrease from the number of companies cited in the previous year.

The citations in the county include:

• Your plant was not constructed to facilitate maintenance and sanitary operations.
• You did not clean and sanitize your utensils or equipment in a manner that protects against contamination.
• You did not to protect against contamination of food.

All of the companies cited were involved in either Food and Cosmetics, 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.

According to its website, 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.

Company Name	Area of Business	Inspection Date	Issue Cited
La Central Bakery, LLC	Food and Cosmetics	02/22/2024	Plant construction and design
La Central Bakery, LLC	Food and Cosmetics	02/22/2024	Sanitary operations - Plant sanitation
La Central Bakery, LLC	Food and Cosmetics	02/22/2024	Pest control
La Central Bakery, LLC	Food and Cosmetics	02/22/2024	Sanitary facilities and controls
La Central Bakery, LLC	Food and Cosmetics	02/22/2024	Plant operations - Precautions
Masterbilt Incorporated	Devices	06/21/2024	Process control procedures, Lack of or inadequate procedures
Masterbilt Incorporated	Devices	06/21/2024	Maintenance schedule, Lack of or inadequate schedule
Masterbilt Incorporated	Devices	06/21/2024	Lack of or inadequate process validation
Masterbilt Incorporated	Devices	06/21/2024	Lack/Inad procedure-Monitoring/Control of Validated Proces
Masterbilt Incorporated	Devices	06/21/2024	Nonconforming product, Lack of or inadequate procedures
Masterbilt Incorporated	Devices	06/21/2024	Lack of or inadequate procedures
Masterbilt Incorporated	Devices	06/21/2024	DHR - not or inadequately maintained
Tri-, Inc., PAC	Drugs	11/08/2024	Representative Samples Criteria