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
This is a 36.3% decrease from the number of companies inspected in the previous year, when 204 companies received 208 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 Biologics sector.
There were 84 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (64.6%). 39 should take voluntary action to correct the organization's management operations (30%). Additionally, eight companies had to take regulatory and/or administrative actions (6.2%).
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 | Result |
---|---|---|---|
A. B. Company, Inc. | Food and Cosmetics | 03/22/2024 | Voluntary Action Indicated (VAI) |
Advocate Christ Medical Center Transfusion Services | Biologics | 10/25/2024 | No Action Indicated (NAI) |
Advocate Lutheran General Hospital Transfusion Services | Biologics | 12/05/2024 | Voluntary Action Indicated (VAI) |
AltaThera Pharmaceuticals, LLC | Drugs | 02/23/2024 | No Action Indicated (NAI) |
Amtrak Maintenance Facility | Food and Cosmetics | 05/29/2024 | Voluntary Action Indicated (VAI) |
Amtrak Maintenance Facility | Food and Cosmetics | 10/03/2024 | No Action Indicated (NAI) |
Anglo Freight USA, Inc. | Food and Cosmetics | 07/01/2024 | Official Action Indicated (OAI) |
Ann and Robert H. Lurie Children's Hospital of Chicago IRB | Biologics | 05/14/2024 | No Action Indicated (NAI) |
Ann and Robert H. Lurie Children's Hospital of Chicago IRB | Devices | 05/14/2024 | No Action Indicated (NAI) |
Ann and Robert H. Lurie Children's Hospital of Chicago IRB | Drugs | 05/14/2024 | No Action Indicated (NAI) |
Arxium, Inc. | Devices | 04/01/2024 | Voluntary Action Indicated (VAI) |
Avieta USA, LLC | Food and Cosmetics | 09/17/2024 | No Action Indicated (NAI) |
Avlon Industries, Inc. | Drugs | 07/15/2024 | Official Action Indicated (OAI) |
Bajaj Medical, LLC | Drugs | 12/04/2024 | Voluntary Action Indicated (VAI) |
Baxter Healthcare Corporation | Drugs | 02/06/2024 | No Action Indicated (NAI) |
Best Choice Meats | Food and Cosmetics | 06/04/2024 | No Action Indicated (NAI) |
Bimbo Bakeries USA | Food and Cosmetics | 02/07/2024 | No Action Indicated (NAI) |
Bimbo Bakeries USA | Veterinary | 02/07/2024 | No Action Indicated (NAI) |
Biomat USA, Inc. | Biologics | 06/28/2024 | No Action Indicated (NAI) |
Blake'S Seed Based, LLC | Food and Cosmetics | 06/18/2024 | No Action Indicated (NAI) |
Blommer Chocolate Company | Food and Cosmetics | 07/22/2024 | No Action Indicated (NAI) |
Bozic'S Imports & Wholesale Liquors | Food and Cosmetics | 08/26/2024 | No Action Indicated (NAI) |
CSL Plasma, Inc. | Biologics | 03/21/2024 | No Action Indicated (NAI) |
Caldic USA, Inc. | Drugs | 08/15/2024 | Voluntary Action Indicated (VAI) |
Caldic USA, Inc. | Veterinary | 08/15/2024 | No Action Indicated (NAI) |
Canyon Foods, Inc. | Food and Cosmetics | 09/05/2024 | No Action Indicated (NAI) |
CellTrans, Inc. | Biologics | 01/16/2024 | No Action Indicated (NAI) |
Chemblend of America, LLC | Drugs | 06/07/2024 | Official Action Indicated (OAI) |
Chester Pilat Bakery & Pastry, Inc. | Food and Cosmetics | 01/31/2024 | No Action Indicated (NAI) |
Chicago Housewares, Inc. | Food and Cosmetics | 02/26/2024 | Voluntary Action Indicated (VAI) |
Chicago Indoor Garden, Inc. | Food and Cosmetics | 09/24/2024 | Voluntary Action Indicated (VAI) |
Chicago Seafood & Restaurant Supply, Inc. | Food and Cosmetics | 07/03/2024 | No Action Indicated (NAI) |
Closed Loop Farms, LLC | Food and Cosmetics | 06/25/2024 | No Action Indicated (NAI) |
Coapt, LLC | Devices | 10/28/2024 | Voluntary Action Indicated (VAI) |
DO&Company Chicago Catering | Food and Cosmetics | 11/29/2024 | Voluntary Action Indicated (VAI) |
David M. Lubeck, M.D. | Drugs | 11/19/2024 | No Action Indicated (NAI) |
Dustin R. Fraidenburg, M.D. | Devices | 07/17/2024 | No Action Indicated (NAI) |
E-Z Spuds, Inc. | Food and Cosmetics | 12/06/2024 | No Action Indicated (NAI) |
Eco Food Distribution, LLC | Food and Cosmetics | 02/07/2024 | Voluntary Action Indicated (VAI) |
El Rey USA Meats & Seafood, Inc. | Food and Cosmetics | 02/12/2024 | No Action Indicated (NAI) |
Essations, Inc. | Drugs | 06/06/2024 | Voluntary Action Indicated (VAI) |
Euphrates Food, LLC | Food and Cosmetics | 04/04/2024 | Official Action Indicated (OAI) |
Evanston Hospital Blood Bank | Biologics | 09/11/2024 | No Action Indicated (NAI) |
Eversight Illinois | Biologics | 06/18/2024 | Voluntary Action Indicated (VAI) |
Feed My Starving Children | Food and Cosmetics | 03/11/2024 | No Action Indicated (NAI) |
First Priority, Inc. | Veterinary | 07/30/2024 | Voluntary Action Indicated (VAI) |
Fish Fridge, LLC | Food and Cosmetics | 08/06/2024 | Voluntary Action Indicated (VAI) |
Five Star Trading IL, Inc. | Food and Cosmetics | 06/14/2024 | Official Action Indicated (OAI) |
Flextronics International USA, Inc. | Devices | 09/06/2024 | No Action Indicated (NAI) |
Fresh Express Incorporated | Food and Cosmetics | 07/19/2024 | Voluntary Action Indicated (VAI) |
Fresh Express Incorporated | Food and Cosmetics | 04/05/2024 | No Action Indicated (NAI) |
GE Healthcare, Inc. | Drugs | 03/08/2024 | Voluntary Action Indicated (VAI) |
Gelita USA -Chicago, Inc. | Food and Cosmetics | 11/07/2024 | No Action Indicated (NAI) |
Georgis, Inc. | Food and Cosmetics | 04/12/2024 | No Action Indicated (NAI) |
Graham Chemical, CORP | Food and Cosmetics | 02/21/2024 | No Action Indicated (NAI) |
Great Wall Seafood, LLC | Food and Cosmetics | 08/09/2024 | Voluntary Action Indicated (VAI) |
Grecian Delight/Kronos | Food and Cosmetics | 12/03/2024 | No Action Indicated (NAI) |
Griffith Foods, Inc. | Food and Cosmetics | 02/09/2024 | No Action Indicated (NAI) |
Hammacher Schlemmer | Food and Cosmetics | 11/26/2024 | No Action Indicated (NAI) |
Healthcare-id, Inc. | Biologics | 07/18/2024 | Voluntary Action Indicated (VAI) |
Home Run INN, Inc. | Food and Cosmetics | 03/19/2024 | No Action Indicated (NAI) |
House of Spices, Inc. | Food and Cosmetics | 04/22/2024 | No Action Indicated (NAI) |
IKEA Food Supply, Inc. | Food and Cosmetics | 02/05/2024 | Voluntary Action Indicated (VAI) |
IKEA Food Supply, Inc. | Veterinary | 02/05/2024 | Voluntary Action Indicated (VAI) |
Instantwhip-Chicago, Inc. | Food and Cosmetics | 08/27/2024 | No Action Indicated (NAI) |
Interstate Blood Bank of Missouri, Inc. | Biologics | 11/14/2024 | No Action Indicated (NAI) |
J. Carlos, Inc. | Food and Cosmetics | 12/16/2024 | No Action Indicated (NAI) |
JFC International, Inc. | Food and Cosmetics | 02/01/2024 | No Action Indicated (NAI) |
Jeron Electronic Systems, Inc. | Devices | 12/04/2024 | Voluntary Action Indicated (VAI) |
John G. Sonnenberg, Ph. D. | Drugs | 04/02/2024 | Voluntary Action Indicated (VAI) |
Joseph L. Newberg, M.D. | Biologics | 06/14/2024 | No Action Indicated (NAI) |
Jyoti D. Patel, M.D. | Drugs | 01/18/2024 | No Action Indicated (NAI) |
Kashiv BioSciences, LLC | Drugs | 06/14/2024 | Voluntary Action Indicated (VAI) |
Keurig Dr Pepper | Food and Cosmetics | 02/01/2024 | Voluntary Action Indicated (VAI) |
Key Foods Company | Food and Cosmetics | 04/25/2024 | Official Action Indicated (OAI) |
Lifeway Foods, Inc. | Food and Cosmetics | 01/31/2024 | No Action Indicated (NAI) |
Lifeway Foods, Inc. | Food and Cosmetics | 01/31/2024 | No Action Indicated (NAI) |
Linde Gas & Equipment, Inc. | Drugs | 09/19/2024 | Voluntary Action Indicated (VAI) |
Long Grove Confectionery, Inc. | Food and Cosmetics | 09/05/2024 | No Action Indicated (NAI) |
Lou Malnati's Priority Pizza, LLC | Food and Cosmetics | 04/24/2024 | No Action Indicated (NAI) |
Loyola University Medical Center | Biologics | 12/05/2024 | Voluntary Action Indicated (VAI) |
Lundbeck Pharmaceuticals, LLC | Drugs | 10/25/2024 | No Action Indicated (NAI) |
Luster Products, Inc. | Drugs | 09/13/2024 | Official Action Indicated (OAI) |
MEDLINE INDUSTRIES, LP - Northfield | Devices | 01/22/2024 | Official Action Indicated (OAI) |
MEDLINE INDUSTRIES, LP - Northfield | Devices | 01/22/2024 | Voluntary Action Indicated (VAI) |
Madina Traders, Inc. | Food and Cosmetics | 08/08/2024 | No Action Indicated (NAI) |
Mariam S. Aziz, M.D. | Biologics | 09/10/2024 | No Action Indicated (NAI) |
Mars Foods US | Food and Cosmetics | 01/11/2024 | Voluntary Action Indicated (VAI) |
Melanie M. Makhija, M.D. | Biologics | 05/13/2024 | No Action Indicated (NAI) |
Metame Health, Inc. | Devices | 02/20/2024 | Voluntary Action Indicated (VAI) |
Michael J. Thirman, M.D. | Drugs | 04/09/2024 | No Action Indicated (NAI) |
Michoacan Food Products, Inc. | Food and Cosmetics | 08/28/2024 | No Action Indicated (NAI) |
Midmark Corporation | Devices | 03/14/2024 | No Action Indicated (NAI) |
Mindy L. Simpson, M.D. | Biologics | 01/11/2024 | No Action Indicated (NAI) |
Norfolk Medical Products, Inc. | Devices | 12/18/2024 | No Action Indicated (NAI) |
NorthShore University Health System IRB | Biologics | 02/28/2024 | No Action Indicated (NAI) |
NorthShore University Health System IRB | Devices | 02/28/2024 | No Action Indicated (NAI) |
NorthShore University Health System IRB | Drugs | 02/28/2024 | No Action Indicated (NAI) |
Northwestern Memorial Hospital Blood Bank | Biologics | 09/17/2024 | No Action Indicated (NAI) |
Peninsula Chicago, LLC | Food and Cosmetics | 07/09/2024 | Voluntary Action Indicated (VAI) |
Prinova US, LLC | Food and Cosmetics | 04/04/2024 | No Action Indicated (NAI) |
Quaker Sales & Distribution, Inc. | Food and Cosmetics | 02/05/2024 | No Action Indicated (NAI) |
Quay Corporation, Inc. | Food and Cosmetics | 09/18/2024 | No Action Indicated (NAI) |
RIM Logistics, Ltd. | Food and Cosmetics | 08/13/2024 | No Action Indicated (NAI) |
RJW Logistics Group | Food and Cosmetics | 01/26/2024 | No Action Indicated (NAI) |
RNA Corporation | Drugs | 03/08/2024 | Voluntary Action Indicated (VAI) |
Rana Meal Solutions, LLC | Food and Cosmetics | 12/23/2024 | No Action Indicated (NAI) |
Regal Health Food International, Inc. | Food and Cosmetics | 09/05/2024 | Voluntary Action Indicated (VAI) |
Regeneveda, LLC | Biologics | 06/18/2024 | No Action Indicated (NAI) |
Rog Sports Medicine, Inc. | Devices | 11/12/2024 | No Action Indicated (NAI) |
Rush Center for Advanced Reproductive Care | Biologics | 04/03/2024 | No Action Indicated (NAI) |
Rush University Medical Center Blood Center | Biologics | 09/20/2024 | No Action Indicated (NAI) |
SSF Food Distribution, Inc. | Food and Cosmetics | 03/18/2024 | Voluntary Action Indicated (VAI) |
Sensient Flavors, LLC | Food and Cosmetics | 02/08/2024 | No Action Indicated (NAI) |
Shira N. Dinner, M.D. | Drugs | 01/18/2024 | No Action Indicated (NAI) |
Silesia Flavors, Inc. | Food and Cosmetics | 08/27/2024 | No Action Indicated (NAI) |
Sonali S. Chaudhury, M.D. | Biologics | 10/03/2024 | No Action Indicated (NAI) |
South Chicago Packing, LLC | Food and Cosmetics | 06/18/2024 | No Action Indicated (NAI) |
South Chicago Packing, LLC | Veterinary | 06/18/2024 | No Action Indicated (NAI) |
Stepan Company | Food and Cosmetics | 11/20/2024 | No Action Indicated (NAI) |
Sterigenics International, LLC | Devices | 12/17/2024 | Voluntary Action Indicated (VAI) |
Stiglmeier Sausage Company, Inc. | Food and Cosmetics | 05/15/2024 | No Action Indicated (NAI) |
Taylor Farms Illinois, Inc. | Food and Cosmetics | 11/12/2024 | No Action Indicated (NAI) |
The American National Red Cross | Biologics | 03/28/2024 | No Action Indicated (NAI) |
The Hatchery Chicago/BAKR, LLC | Food and Cosmetics | 02/12/2024 | No Action Indicated (NAI) |
United Airlines, Inc. | Food and Cosmetics | 05/17/2024 | No Action Indicated (NAI) |
United Airlines, Inc. | Food and Cosmetics | 10/04/2024 | No Action Indicated (NAI) |
University of Chicago Medicine - Blood Bank | Biologics | 10/18/2024 | No Action Indicated (NAI) |
University of Chicago Medicine AdventHealth Hinsdale Hospital | Biologics | 06/26/2024 | No Action Indicated (NAI) |
University of Illinois at Chicago In Vitro Fertilization Program | Biologics | 04/04/2024 | No Action Indicated (NAI) |
VHRK Food, Inc. | Food and Cosmetics | 03/27/2024 | Voluntary Action Indicated (VAI) |
Vee Pak, LLC | Drugs | 12/10/2024 | Voluntary Action Indicated (VAI) |
Versiti Illinois, Inc. | Biologics | 06/13/2024 | No Action Indicated (NAI) |
Versiti Illinois, Inc. | Biologics | 11/18/2024 | No Action Indicated (NAI) |
Vitalant | Biologics | 04/04/2024 | No Action Indicated (NAI) |
Vitalant | Biologics | 10/29/2024 | No Action Indicated (NAI) |
Vitalant | Biologics | 01/31/2024 | No Action Indicated (NAI) |
Vitalant Reference and Transfusion Service | Biologics | 11/14/2024 | No Action Indicated (NAI) |
West Madison Foods | Food and Cosmetics | 05/01/2024 | No Action Indicated (NAI) |
Winfar Foods, Inc. | Food and Cosmetics | 02/27/2024 | Voluntary Action Indicated (VAI) |
Wisepak Foods | Food and Cosmetics | 06/05/2024 | Voluntary Action Indicated (VAI) |
Xttrium Laboratories, Inc. | Drugs | 03/08/2024 | Voluntary Action Indicated (VAI) |
Xttrium Laboratories, Inc. | Drugs | 02/06/2024 | No Action Indicated (NAI) |
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