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 |
