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 12.5% decrease from the number of companies inspected in the previous year, when 48 companies were inspected through 51 inspections.
Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Devices sector.
There were 28 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (66.7%). 14 should take voluntary action to correct the organization's management operations (33.3%). Additionally, one company had to take regulatory and/or administrative actions (2.4%).
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.
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 | Result |
|---|---|---|---|
| A-S Medication Solutions, LLC | Drugs | 02/16/2023 | No Action Indicated (NAI) |
| AbbVie, Inc. | Drugs | 01/31/2023 | Voluntary Action Indicated (VAI) |
| AbbVie, Inc. | Veterinary | 01/31/2023 | Voluntary Action Indicated (VAI) |
| Acacia Spice Company | Food/Cosmetics | 05/26/2023 | No Action Indicated (NAI) |
| Advanced Fertility Center of Chicago | Biologics | 04/26/2023 | No Action Indicated (NAI) |
| Aep Group, LLC | Food/Cosmetics | 08/03/2023 | No Action Indicated (NAI) |
| Aherb USA, Inc. | Food/Cosmetics | 03/31/2023 | Voluntary Action Indicated (VAI) |
| Ans Seafood, Inc. | Food/Cosmetics | 12/14/2023 | Voluntary Action Indicated (VAI) |
| Ans Seafood, Inc. | Food/Cosmetics | 12/14/2023 | Voluntary Action Indicated (VAI) |
| Baxter Healthcare Corporation | Devices | 08/18/2023 | Voluntary Action Indicated (VAI) |
| Bende, Inc. | Food/Cosmetics | 03/29/2023 | Voluntary Action Indicated (VAI) |
| Bende, Inc. | Food/Cosmetics | 12/22/2023 | Voluntary Action Indicated (VAI) |
| Blackwing Organic Meats, Inc. | Food/Cosmetics | 07/13/2023 | Voluntary Action Indicated (VAI) |
| Bozic'S Imports & Wholesale Liquors | Food/Cosmetics | 07/19/2023 | Voluntary Action Indicated (VAI) |
| Capol, LLC | Food/Cosmetics | 05/04/2023 | No Action Indicated (NAI) |
| Cardinal Health 200, LLC | Devices | 05/05/2023 | No Action Indicated (NAI) |
| Cheshni Foods, LLC | Food/Cosmetics | 11/17/2023 | Voluntary Action Indicated (VAI) |
| Cheshni Foods, LLC | Food/Cosmetics | 04/28/2023 | Official Action Indicated (OAI) |
| Dessertwerks, Inc. | Food/Cosmetics | 02/02/2023 | No Action Indicated (NAI) |
| FMI, LLC | Devices | 10/23/2023 | No Action Indicated (NAI) |
| FiMex, Inc. | Food/Cosmetics | 05/12/2023 | Voluntary Action Indicated (VAI) |
| FiMex, Inc. | Food/Cosmetics | 10/20/2023 | Voluntary Action Indicated (VAI) |
| Giannetti Artisans, Inc. | Food/Cosmetics | 09/28/2023 | Voluntary Action Indicated (VAI) |
| Graham Chemical, CORP | Food/Cosmetics | 08/30/2023 | No Action Indicated (NAI) |
| Greater Than | Food/Cosmetics | 09/28/2023 | No Action Indicated (NAI) |
| Isomedix Operations, Inc. | Drugs | 09/18/2023 | Voluntary Action Indicated (VAI) |
| J R Carlson Laboratories, Inc. | Food/Cosmetics | 06/30/2023 | No Action Indicated (NAI) |
| K. M. J. Enterprises, Inc. | Food/Cosmetics | 04/03/2023 | No Action Indicated (NAI) |
| Kraft Chemical Company | Food/Cosmetics | 03/03/2023 | No Action Indicated (NAI) |
| LeMaitre Vascular, Inc. | Biologics | 03/29/2023 | No Action Indicated (NAI) |
| Matt's Cookie Company | Food/Cosmetics | 06/29/2023 | No Action Indicated (NAI) |
| Medline Industries LP | Devices | 11/01/2023 | No Action Indicated (NAI) |
| Medline Industries, Inc. | Drugs | 07/12/2023 | Voluntary Action Indicated (VAI) |
| Micro Measurement Laboratories, Inc. | Drugs | 02/23/2023 | Voluntary Action Indicated (VAI) |
| Micro Measurement Laboratories, Inc. | Veterinary | 02/23/2023 | Voluntary Action Indicated (VAI) |
| Northwest Community Healthcare | Biologics | 02/09/2023 | No Action Indicated (NAI) |
| O'My Goodness | Food/Cosmetics | 02/23/2023 | No Action Indicated (NAI) |
| Pfanstiehl, Inc. | Drugs | 01/23/2023 | No Action Indicated (NAI) |
| Plexus Corporation | Devices | 05/25/2023 | No Action Indicated (NAI) |
| Quadrant Technologies, LLC | Devices | 10/12/2023 | No Action Indicated (NAI) |
| Richard Wolf Medical Instruments Corporation | Devices | 04/19/2023 | No Action Indicated (NAI) |
| SGS North America, Inc. | Drugs | 01/10/2023 | Voluntary Action Indicated (VAI) |
| SGS North America, Inc. | Veterinary | 01/10/2023 | Voluntary Action Indicated (VAI) |
| Salud Natural Entrepreneur, Inc. | Food/Cosmetics | 03/15/2023 | No Action Indicated (NAI) |
| Sysmex America, Inc. | Devices | 03/02/2023 | No Action Indicated (NAI) |
| Viant Medical | Devices | 06/12/2023 | No Action Indicated (NAI) |
| Vitalant | Biologics | 02/07/2023 | No Action Indicated (NAI) |
| Woodland Foods | Food/Cosmetics | 12/13/2023 | No Action Indicated (NAI) |
| Woodland Foods, LLC | Food/Cosmetics | 12/18/2023 | No Action Indicated (NAI) |
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