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Thursday, November 21, 2024

How many companies in cities across Ramsey County received FDA citations in 2023?

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

There were 12 companies in cities associated with Ramsey County that received FDA citations as a result of 13 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 7.7% decrease from the number of companies cited in the previous year.

Of the 35 citations issued, the most common citation was 'You did not take a reasonable measure or precaution related to personnel practices'.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

Of the companies cited, 12 should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (8.3%).

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.

Companies Located Within Ramsey County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Aarthun Enterprises, LLCFood and Cosmetics09/08/2023Food safety plan
Bergin Fruit Company, Inc.Food and Cosmetics09/08/2023Personnel
Bergin Fruit Company, Inc.Food and Cosmetics09/08/2023Equipment and utensils - Design and maintenance
Bergin Fruit Company, Inc.Food and Cosmetics09/08/2023Allergen preventive controls - Implementation records
Blackeye Beverage, LLCFood and Cosmetics06/22/2023Thermal process crit factors-measurement adequate & accurate
Blackeye Beverage, LLCFood and Cosmetics06/22/2023Other systems - records; critical factors
Blackeye Beverage, LLCFood and Cosmetics06/22/2023Review of processing and production records
Ermi GebeyaFood and Cosmetics03/10/2023Develop FSVP
Ermi GebeyaFood and Cosmetics03/10/2023Identification - entry
Gaoyoua Bakery, LLCFood and Cosmetics10/25/2023Personnel
Gaoyoua Bakery, LLCFood and Cosmetics10/25/2023Sanitary facilities and controls
Gaoyoua Bakery, LLCFood and Cosmetics10/25/2023Modified requirement: Temperature control - Records
IntriCon CorporationDevices04/17/2023Contamination control, Lack of or inadequate procedures
Lacteos Mi Chalatenango, Inc.Food and Cosmetics09/27/2023Very small importer assurances, supplier
Lacteos Mi Chalatenango, Inc.Food and Cosmetics03/22/2023Develop FSVP
Lovejoys Bloody Mary MixFood and Cosmetics01/23/2023Process filing
Lovejoys Bloody Mary MixFood and Cosmetics01/23/2023Maintenance of processing and production records
MinnSprouts, LLCFood and Cosmetics05/16/2023Training for supervisors
MinnSprouts, LLCFood and Cosmetics05/16/2023Hygienic practices
MinnSprouts, LLCFood and Cosmetics05/16/2023Food contact surface sanitary inspection and maintenance
MinnSprouts, LLCFood and Cosmetics05/16/2023Buildings - drainage
MinnSprouts, LLCFood and Cosmetics05/16/2023Written environmental monitoring plan
MinnSprouts, LLCFood and Cosmetics05/16/2023Written sampling plan for spent irrigation water or sprouts
MinnSprouts, LLCFood and Cosmetics05/16/2023Analytical testing record
RSP Prodo, LLCFood and Cosmetics06/28/2023Personnel
RSP Prodo, LLCFood and Cosmetics06/28/2023Plant construction and design
RSP Prodo, LLCFood and Cosmetics06/28/2023Equipment and utensils - Design and maintenance
RSP Prodo, LLCFood and Cosmetics06/28/2023Manufacturing, processing, packing, holding - Controls
RSP Prodo, LLCFood and Cosmetics06/28/2023Storage and Distribution
RSP Prodo, LLCFood and Cosmetics06/28/2023Training records - General requirements
Smiths Medical ASD, Inc.Devices06/09/2023Process control procedures, Lack of or inadequate procedures
Smiths Medical ASD, Inc.Devices06/09/2023Nonconforming product, Lack of or inadequate procedures
Westway Feed Products, LLCVeterinary12/07/2023Three assays per year
Westway Feed Products, LLCVeterinary12/07/2023Assay results out of specification
Westway Feed Products, LLCVeterinary12/07/2023Prevention of unsafe contamination by equipment

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