Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 13.5% decrease from the number of companies inspected in the previous year, when 74 companies received 130 inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics sector. The second most common type of company inspected period worked in the Devices sector.
There were 34 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (53.1%). 28 should take voluntary action to correct the organization's management operations (43.8%). Additionally, two companies had to take regulatory and/or administrative actions (3.1%).
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.
Companies Located in Cities Within Hennepin County and Their Inspection Results
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| Abbott | Devices | 06/28/2024 | Voluntary Action Indicated (VAI) |
| Agrex, Inc. | Food and Cosmetics | 03/20/2024 | Voluntary Action Indicated (VAI) |
| Amerilab Technologies, Inc. | Food and Cosmetics | 03/14/2024 | No Action Indicated (NAI) |
| At Last ! Gourmet Foods, Inc. | Food and Cosmetics | 07/24/2024 | No Action Indicated (NAI) |
| Bellisio Foods, Inc. | Food and Cosmetics | 11/26/2024 | No Action Indicated (NAI) |
| Beyond the Grain, LLC | Food and Cosmetics | 08/07/2024 | No Action Indicated (NAI) |
| Biomedix Wai | Devices | 11/18/2024 | No Action Indicated (NAI) |
| Capital Imports, LLC | Food and Cosmetics | 02/23/2024 | Official Action Indicated (OAI) |
| Cheryl's Nut Butters | Food and Cosmetics | 03/27/2024 | No Action Indicated (NAI) |
| Children's Hospital & Clinics of Minnesota | Biologics | 10/09/2024 | No Action Indicated (NAI) |
| Chitogen, Inc. | Devices | 03/19/2024 | Voluntary Action Indicated (VAI) |
| Cirtec Medical, Corp. | Devices | 03/20/2024 | No Action Indicated (NAI) |
| Citrus Systems, Inc. | Food and Cosmetics | 04/04/2024 | Voluntary Action Indicated (VAI) |
| Cre 8 It, Inc. | Food and Cosmetics | 07/12/2024 | Voluntary Action Indicated (VAI) |
| Delta Air Lines | Food and Cosmetics | 01/02/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/02/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/09/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/22/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/30/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 02/02/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 03/06/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 03/11/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 03/11/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 04/08/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 04/08/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 04/19/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 04/22/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 04/23/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 05/06/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 05/10/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 05/10/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 05/28/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 06/03/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 06/10/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 07/09/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 07/09/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 08/05/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 08/23/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 09/10/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 09/17/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 09/25/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 10/23/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 11/05/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 11/07/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 11/08/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 11/18/2024 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 12/30/2024 | No Action Indicated (NAI) |
| Desserts by Alighieri, Inc. | Food and Cosmetics | 02/09/2024 | Voluntary Action Indicated (VAI) |
| Dr In The Kitchen, LLC | Food and Cosmetics | 04/22/2024 | Voluntary Action Indicated (VAI) |
| Dreamland Trading, Inc. | Food and Cosmetics | 09/30/2024 | No Action Indicated (NAI) |
| Elucent Medical, Inc. | Devices | 11/19/2024 | No Action Indicated (NAI) |
| Federal Package Network, Inc. | Drugs | 12/13/2024 | Voluntary Action Indicated (VAI) |
| Fred S. Apple, PhD, Clinical Investigator | Devices | 02/28/2024 | No Action Indicated (NAI) |
| Gopher Mats, LLC | Food and Cosmetics | 01/18/2024 | No Action Indicated (NAI) |
| Gopher Mats, LLC | Veterinary | 01/18/2024 | No Action Indicated (NAI) |
| Hangtime | Food and Cosmetics | 12/13/2024 | Voluntary Action Indicated (VAI) |
| Holiday Stationstores, LLC | Food and Cosmetics | 08/09/2024 | Voluntary Action Indicated (VAI) |
| Innovative Blood Resources, a Division of New York Blood Center, Inc. | Biologics | 06/27/2024 | No Action Indicated (NAI) |
| Innovative Blood Resources, a Division of New York Blood Center, Inc. | Biologics | 06/26/2024 | No Action Indicated (NAI) |
| Jansen Enterprises, LLC | Food and Cosmetics | 02/16/2024 | Voluntary Action Indicated (VAI) |
| Jessica A. Thomes-Pepin, M.D. | Drugs | 04/08/2024 | Voluntary Action Indicated (VAI) |
| LA Parcela Produce, LLC | Food and Cosmetics | 03/26/2024 | Official Action Indicated (OAI) |
| Lund Food Holdings, Inc. | Food and Cosmetics | 07/30/2024 | Voluntary Action Indicated (VAI) |
| M Health Fairview University of Minnesota Medical Center, East Bank-Blood Bank | Biologics | 09/06/2024 | No Action Indicated (NAI) |
| Medsource International, LLC | Devices | 01/18/2024 | No Action Indicated (NAI) |
| Medspira, LLC | Devices | 01/16/2024 | Voluntary Action Indicated (VAI) |
| Medtronic Care Management Services | Devices | 02/01/2024 | No Action Indicated (NAI) |
| NeuroOne Medical Technologies Corporation | Devices | 10/28/2024 | Voluntary Action Indicated (VAI) |
| Nightware | Devices | 07/01/2024 | Voluntary Action Indicated (VAI) |
| Nonin Medical, Inc. | Devices | 07/18/2024 | No Action Indicated (NAI) |
| PMT Corporation | Devices | 02/15/2024 | Voluntary Action Indicated (VAI) |
| Padagis US, LLC | Drugs | 09/06/2024 | Voluntary Action Indicated (VAI) |
| Padagis US, LLC | Drugs | 01/31/2024 | No Action Indicated (NAI) |
| Pathy Medical, LLC | Devices | 11/19/2024 | Voluntary Action Indicated (VAI) |
| Pharmaganics, LLC | Food and Cosmetics | 07/16/2024 | Voluntary Action Indicated (VAI) |
| Phoenician Mediterranean Food | Food and Cosmetics | 02/16/2024 | No Action Indicated (NAI) |
| Phraxis, Inc. | Devices | 12/18/2024 | No Action Indicated (NAI) |
| Precison, Inc. | Devices | 07/10/2024 | No Action Indicated (NAI) |
| Premier Biotech, Inc. | Devices | 07/23/2024 | Voluntary Action Indicated (VAI) |
| ProMed Pharma, LLC | Devices | 02/21/2024 | Voluntary Action Indicated (VAI) |
| Respicardia, Inc. | Devices | 03/22/2024 | No Action Indicated (NAI) |
| Responsive Arthroscopy, LLC | Devices | 05/30/2024 | No Action Indicated (NAI) |
| Scott D. Anseth, Clinical Investigator, M.D. | Devices | 01/24/2024 | No Action Indicated (NAI) |
| Silk Road Medical | Devices | 01/23/2024 | Voluntary Action Indicated (VAI) |
| Smokeless Smoking, Inc. | Tobacco | 01/03/2024 | No Action Indicated (NAI) |
| So Good Brand, Inc. | Food and Cosmetics | 05/03/2024 | Voluntary Action Indicated (VAI) |
| Solid Gold Northland Health Products for Pets | Veterinary | 05/13/2024 | Voluntary Action Indicated (VAI) |
| Sterilmed, Inc. | Devices | 05/22/2024 | Voluntary Action Indicated (VAI) |
| Suddath Moving and Storage of Minnesota, LLC | Food and Cosmetics | 06/21/2024 | No Action Indicated (NAI) |
| Supervalu Grocery District Center | Food and Cosmetics | 06/05/2024 | Voluntary Action Indicated (VAI) |
| TacPro, LLC | Devices | 02/22/2024 | Voluntary Action Indicated (VAI) |
| Target Corporation | Food and Cosmetics | 01/26/2024 | No Action Indicated (NAI) |
| Teleflex Medical OEM, LLC | Devices | 01/26/2024 | No Action Indicated (NAI) |
| Terra Ingredients, LLC | Food and Cosmetics | 02/12/2024 | No Action Indicated (NAI) |
| Tortilla Payan | Food and Cosmetics | 01/24/2024 | No Action Indicated (NAI) |
| Urocure, LLC | Devices | 06/07/2024 | No Action Indicated (NAI) |
| VA Health Care System - Blood Bank | Biologics | 07/19/2024 | No Action Indicated (NAI) |
| Viterra USA, LLC | Food and Cosmetics | 09/05/2024 | No Action Indicated (NAI) |
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