South Hennepin News

There were 27 companies in cities associated with Hennepin County that received FDA citations as a result of 27 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is an 8% increase over the number of companies cited in the previous year.

Of the 73 citations issued, the most common citation was '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 Devices sector.

Of the companies cited, 25 should take voluntary actions to correct their managing operations (92.6%). Additionally, two companies had to take regulatory and/or administrative actions (7.4%).

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
Abbott	Devices	06/28/2024	Sponsors' general responsibilities
Abbott	Devices	06/28/2024	Device return/disposal by non-compliant investigator
Abbott	Devices	06/28/2024	Sponsor securing investigator compliance
Agrex, Inc.	Food and Cosmetics	03/20/2024	Develop FSVP
Agrex, Inc.	Food and Cosmetics	03/20/2024	Identification - entry
Capital Imports, LLC	Food and Cosmetics	02/23/2024	Develop FSVP
Chitogen, Inc.	Devices	03/19/2024	Documentation
Chitogen, Inc.	Devices	03/19/2024	Lack of or inadequate procedures
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
Cre 8 It, Inc.	Food and Cosmetics	07/12/2024	Plant construction and design
Desserts by Alighieri, Inc.	Food and Cosmetics	02/09/2024	Manufacturing, processing, packing, holding - Controls
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
Hangtime	Food and Cosmetics	12/13/2024	Process deviation evaluation - record
Hangtime	Food and Cosmetics	12/13/2024	Raw materials, packaging, finished product
Hangtime	Food and Cosmetics	12/13/2024	Maintenance of processing and production records
Hangtime	Food and Cosmetics	12/13/2024	Equipment and utensils - Design and maintenance
Holiday Stationstores, LLC	Food and Cosmetics	08/09/2024	Personnel
Holiday Stationstores, LLC	Food and Cosmetics	08/09/2024	Hazard analysis - Identification of hazard
Holiday Stationstores, LLC	Food and Cosmetics	08/09/2024	Allergen preventive controls - Appropriate (Adequate)
Jessica A. Thomes-Pepin, M.D.	Drugs	04/08/2024	Case history records- inadequate or inadequate
LA Parcela Produce, LLC	Food and Cosmetics	03/26/2024	Develop FSVP
LA Parcela Produce, LLC	Food and Cosmetics	03/26/2024	Hazard analysis biological, chemical, physical
LA Parcela Produce, LLC	Food and Cosmetics	03/26/2024	Supplier verification - establish written procedures
LA Parcela Produce, LLC	Food and Cosmetics	03/26/2024	Verification activity assurance
LA Parcela Produce, LLC	Food and Cosmetics	03/26/2024	Verification activity before import, periodically
Lund Food Holdings, Inc.	Food and Cosmetics	07/30/2024	Personnel
Lund Food Holdings, Inc.	Food and Cosmetics	07/30/2024	Plant operations - Precautions
Lund Food Holdings, Inc.	Food and Cosmetics	07/30/2024	Hazard analysis - Identification of hazard
Lund Food Holdings, Inc.	Food and Cosmetics	07/30/2024	Allergen preventive controls - Implement
Lund Food Holdings, Inc.	Food and Cosmetics	07/30/2024	HACCP plan implementation
Lund Food Holdings, Inc.	Food and Cosmetics	07/30/2024	Critical control points
Lund Food Holdings, Inc.	Food and Cosmetics	07/30/2024	Sanitation monitoring
Medspira, LLC	Devices	01/16/2024	Lack of System for Event Evaluations
Medspira, LLC	Devices	01/16/2024	Design plans - Lack of or inadequate
Medspira, LLC	Devices	01/16/2024	Design validation - Risk analysis
Medspira, LLC	Devices	01/16/2024	Design changes - Lack of or Inadequate Procedures
Medspira, LLC	Devices	01/16/2024	Design history file
Medspira, LLC	Devices	01/16/2024	Nonconforming product, Lack of or inadequate procedures
Medspira, LLC	Devices	01/16/2024	Lack of or inadequate procedures
Medspira, LLC	Devices	01/16/2024	Lack of or inadequate complaint procedures
NeuroOne Medical Technologies Corporation	Devices	10/28/2024	Design Validation - Risk analysis not performed/inadequate
NeuroOne Medical Technologies Corporation	Devices	10/28/2024	Design validation- Lack of or inadequate procedures
Nightware	Devices	07/01/2024	Design validation - software validation not performed
Nightware	Devices	07/01/2024	Procedures not adequately established or maintained
PMT Corporation	Devices	02/15/2024	Design Validation - Risk analysis not performed/inadequate
PMT Corporation	Devices	02/15/2024	Calibration, Inspection, etc. Procedures Lack of or Inadequ
PMT Corporation	Devices	02/15/2024	Lack of or inadequate procedures
PMT Corporation	Devices	02/15/2024	Investigation of device failures
Padagis US, LLC	Drugs	09/06/2024	Cleaning SOP/inspection
Pathy Medical, LLC	Devices	11/19/2024	Management review - defined interval, sufficient frequency
Pathy Medical, LLC	Devices	11/19/2024	Lack/Inad procedure-Monitoring/Control of Validated Proces
Pathy Medical, LLC	Devices	11/19/2024	Lack of or inadequate procedures
Pharmaganics, LLC	Food and Cosmetics	07/16/2024	Quality control - quality, dietary supplement
ProMed Pharma, LLC	Devices	02/21/2024	Lack of or inadequate procedures
Silk Road Medical	Devices	01/23/2024	Calibration, Inspection, etc. Procedures Lack of or Inadequ
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
Solid Gold Northland Health Products for Pets	Veterinary	05/13/2024	Develop FSVP
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
Supervalu Grocery District Center	Food and Cosmetics	06/05/2024	Identification - entry
TacPro, LLC	Devices	02/22/2024	Training - Lack of or inadequate procedures