Minneapolis Review

There were four companies in cities associated with Hennepin County that received FDA citations as a result of four inspections conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 42.9% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• You did not maintain your plant in a clean and sanitary condition and in adequate repair.
• You did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms.
• You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with current good manufacturing practice including protection of food, food packaging material, and food contact surfaces from adulteration.

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
Citrus Systems, Inc.	Food and Cosmetics	04/04/2024	Sanitary operations - Plant maintenance
Citrus Systems, Inc.	Food and Cosmetics	04/04/2024	Manufacturing, processing, packing, holding - Controls
Citrus Systems, Inc.	Food and Cosmetics	04/04/2024	Sanitation monitoring
Dr In The Kitchen, LLC	Food and Cosmetics	04/22/2024	Personnel
Dr In The Kitchen, LLC	Food and Cosmetics	04/22/2024	Plant construction and design
Dr In The Kitchen, LLC	Food and Cosmetics	04/22/2024	Sanitary operations - Plant sanitation
Dr In The Kitchen, LLC	Food and Cosmetics	04/22/2024	Cleaning and sanitizing substances - Safe and adequate
Dr In The Kitchen, LLC	Food and Cosmetics	04/22/2024	Process control - Foreign objects
Dr In The Kitchen, LLC	Food and Cosmetics	04/22/2024	Hazard analysis - Identification of hazard
So Good Brand, Inc.	Food and Cosmetics	05/03/2024	Sanitation monitoring
So Good Brand, Inc.	Food and Cosmetics	05/03/2024	HACCP plan - monitoring procedures - none listed
So Good Brand, Inc.	Food and Cosmetics	05/03/2024	Corrective action - predetermined plan inadequate
So Good Brand, Inc.	Food and Cosmetics	05/03/2024	Calibration, testing - record review adequacy
So Good Brand, Inc.	Food and Cosmetics	05/03/2024	Records - actual values
Sterilmed, Inc.	Devices	05/22/2024	Design Validation - Risk analysis not performed/inadequate
Sterilmed, Inc.	Devices	05/22/2024	Production processes
Sterilmed, Inc.	Devices	05/22/2024	Lack of or inadequate procedures