South Hennepin News

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

This is a 20% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Procedures for design validation have not been adequately established.
• You did not store and maintain equipment and tools to protect covered produce from being contaminated with foreseeable hazards.
• You did not sanitize food contact surfaces as frequently as necessary to protect against the contamination of produce.

Most of the companies cited were involved in the Food and Cosmetics sector.

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
Brothers Imports, LLP	Food and Cosmetics	11/15/2023	Pest control
Calco Sprouts	Food and Cosmetics	11/27/2023	Equip & tools - storage
Calco Sprouts	Food and Cosmetics	11/27/2023	Food contact surface sanitary inspection and maintenance
Calco Sprouts	Food and Cosmetics	11/27/2023	Buildings - prevent contamination
Calco Sprouts	Food and Cosmetics	11/27/2023	Corrective action components of an environmental monitoring plan
Calco Sprouts	Food and Cosmetics	11/27/2023	Method - Water quality
Great Northern Baking Company, Inc.	Food and Cosmetics	11/17/2023	Sanitary operations - Plant maintenance
Great Northern Baking Company, Inc.	Food and Cosmetics	11/17/2023	Equipment and utensils - Design and maintenance
ProMed Pharma, LLC	Drugs	10/17/2023	Items to cover on annual reviews
Provita Supplements, Inc.	Veterinary	10/27/2023	Develop FSVP
Provita Supplements, Inc.	Veterinary	10/27/2023	Hazard analysis written
Winter Innovations, Inc.	Devices	12/01/2023	Design validation- Lack of or inadequate procedures