South Hennepin News

There were 23 companies in cities associated with Hennepin County that received FDA citations as a result of 23 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 30.3% decrease from the number of companies cited in the previous year.

Of the 68 citations issued, the most common citations were 'You did not develop an FSVP' and 'Procedures for corrective and preventive action have not been adequately established'.

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, 20 should take voluntary actions to correct their managing operations (87%). Additionally, one company had to take regulatory and/or administrative actions (4.3%).

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Annex Medical, Inc.	Devices	06/09/2023	Contamination control, Lack of or inadequate procedures
Annex Medical, Inc.	Devices	06/09/2023	Lack of or inadequate procedures - Acceptance activities
Annex Medical, Inc.	Devices	06/09/2023	Lack of or inadequate procedures
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
Children's Healthcare IRB #1	Biologics	02/03/2023	Members present for review
Children's Healthcare IRB #1	Devices	02/03/2023	Members present for review
Children's Healthcare IRB #1	Drugs	02/03/2023	Members present for review
Culligan Soft Water Service Company	Devices	07/14/2023	Training records
Culligan Soft Water Service Company	Devices	07/14/2023	Maintenance schedule, Lack of or inadequate schedule
Culligan Soft Water Service Company	Devices	07/14/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Culligan Soft Water Service Company	Devices	07/14/2023	Nonconforming product, Lack of or inadequate procedures
Culligan Soft Water Service Company	Devices	07/14/2023	Lack of or inadequate procedures
Culligan Soft Water Service Company	Devices	07/14/2023	Servicing - Lack of or inadequate procedures
East Wholesale, LLC	Food and Cosmetics	03/14/2023	Grounds
East Wholesale, LLC	Food and Cosmetics	03/14/2023	Pest control
Eddie M's	Food and Cosmetics	08/31/2023	Hazard analysis
Funky Chunky, LLC	Food and Cosmetics	02/02/2023	Personnel
Funky Chunky, LLC	Food and Cosmetics	02/02/2023	Sanitary operations - Plant sanitation
Funky Chunky, LLC	Food and Cosmetics	02/02/2023	Sanitary facilities and controls
Funky Chunky, LLC	Food and Cosmetics	02/02/2023	Hazard analysis - Identification of hazard
Funky Chunky, LLC	Food and Cosmetics	02/02/2023	Allergen preventive controls - Implement
Funky Chunky, LLC	Food and Cosmetics	02/02/2023	Allergen preventive controls - Appropriate (Adequate)
Funky Chunky, LLC	Food and Cosmetics	02/02/2023	Sanitation preventive controls - Appropriate (Adequate)
Funky Chunky, LLC	Food and Cosmetics	02/02/2023	Supply-chain program - Records
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
LSG Lufthansa Service Holding Agent	Food and Cosmetics	06/13/2023	Sanitary operations - Plant sanitation
Los Maizalitos, Inc.	Food and Cosmetics	05/25/2023	Personnel
Los Maizalitos, Inc.	Food and Cosmetics	05/25/2023	Plant construction and design
Los Maizalitos, Inc.	Food and Cosmetics	05/25/2023	Sanitary operations - Plant sanitation
Los Maizalitos, Inc.	Food and Cosmetics	05/25/2023	Sanitary facilities and controls
Los Maizalitos, Inc.	Food and Cosmetics	05/25/2023	Equipment and utensils - Design and maintenance
Lund Food Holdings, Inc.	Food and Cosmetics	08/10/2023	Develop FSVP
Medtronic Neuromodulation	Devices	05/05/2023	Lack of System for Event Evaluations
Medtronic Neuromodulation	Devices	05/05/2023	Time to report - 10 days
Medtronic Neuromodulation	Devices	05/05/2023	Lack of or inadequate procedures
Medtronic Neuromodulation	Devices	05/05/2023	Investigation of device failures
Minnesota Halal Market, LLC.	Food and Cosmetics	08/08/2023	Develop FSVP
Minnesota Halal Market, LLC.	Food and Cosmetics	08/08/2023	Hazard analysis written
Minnesota Halal Market, LLC.	Food and Cosmetics	08/08/2023	Evaluation - performance, risk
Minnesota Halal Market, LLC.	Food and Cosmetics	08/08/2023	Reevaluate - 3 years
Minnesota Halal Market, LLC.	Food and Cosmetics	08/08/2023	Approved supplier procedures - importer established
Minnesota Halal Market, LLC.	Food and Cosmetics	08/08/2023	Verification activity assurance
Minnesota Halal Market, LLC.	Food and Cosmetics	08/08/2023	Verification activity before import, periodically
Olsen Fish Company	Food and Cosmetics	05/26/2023	Monitoring - adequacy
Pharmaganics, LLC	Food and Cosmetics	09/05/2023	Specifications - contamination limits
Pharmaganics, LLC	Food and Cosmetics	09/05/2023	Written procedures - quality control operations
Pharmaganics, LLC	Food and Cosmetics	09/05/2023	Quality control - supplier qualification
Pharmaganics, LLC	Food and Cosmetics	09/05/2023	Packaging, labeling operations:originals, copies, electronic
Pharmaganics, LLC	Food and Cosmetics	09/05/2023	Records - ret'nd dietary supplement: material review, dispos
Pharmaganics, LLC	Food and Cosmetics	09/05/2023	Record - product complaint; good manufacturing practice
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
Reach Companies, LLC	Food and Cosmetics	04/18/2023	Hazard analysis biological, chemical, physical
Smiths Medical ASD, Inc.	Devices	03/03/2023	Lack of Written MDR Procedures
Smiths Medical ASD, Inc.	Devices	03/03/2023	Nonconforming product, Lack of or inadequate procedures
Smiths Medical ASD, Inc.	Devices	03/03/2023	Lack of or inadequate procedures
Triple Crown Nutrition, Inc.	Veterinary	05/10/2023	Develop FSVP
US Foods Holding, Corp.	Food and Cosmetics	06/15/2023	Food safety hazards
US Foods Holding, Corp.	Food and Cosmetics	06/15/2023	Corrective action per predetermined plan
US Foods Holding, Corp.	Food and Cosmetics	06/15/2023	Calibration - adequacy
Winter Innovations, Inc.	Devices	12/01/2023	Design validation- Lack of or inadequate procedures