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 unchanged from the number of companies inspected in the previous year.
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 27 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (75%). Nine should take voluntary action to correct the organization's management operations (25%).
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 |
|---|---|---|---|
| AJLS Enterprises, Inc. | Food/Cosmetics | 03/23/2023 | No Action Indicated (NAI) |
| Barriques Holding Company, LLC | Food/Cosmetics | 01/12/2023 | No Action Indicated (NAI) |
| Bean Bakery, LLC | Food/Cosmetics | 01/17/2023 | No Action Indicated (NAI) |
| Celletech, Ltd. | Food/Cosmetics | 04/05/2023 | Voluntary Action Indicated (VAI) |
| Claws 2 Paws Animal Supply, LLC | Veterinary | 11/29/2023 | No Action Indicated (NAI) |
| Colorcon, Inc. | Food/Cosmetics | 09/13/2023 | No Action Indicated (NAI) |
| Compass Group USA, Inc. | Food/Cosmetics | 11/27/2023 | Voluntary Action Indicated (VAI) |
| Dairyfood USA, Inc. | Food/Cosmetics | 12/28/2023 | Voluntary Action Indicated (VAI) |
| Datex-Ohmeda, Inc. | Devices | 03/01/2023 | No Action Indicated (NAI) |
| Elegant Foods, LLC | Food/Cosmetics | 07/28/2023 | Voluntary Action Indicated (VAI) |
| Exact Sciences Corporation | Devices | 06/22/2023 | No Action Indicated (NAI) |
| Fire Horse International, LLC | Food/Cosmetics | 02/28/2023 | No Action Indicated (NAI) |
| Generations Fertility Care, Inc. | Biologics | 01/05/2023 | No Action Indicated (NAI) |
| Hanna Agent, LLC | Veterinary | 10/24/2023 | No Action Indicated (NAI) |
| Jurgan Development & Manufacturing, Ltd. | Devices | 04/24/2023 | No Action Indicated (NAI) |
| L'eft Bank Wine Company, Limited | Food/Cosmetics | 05/01/2023 | No Action Indicated (NAI) |
| Lions Eye Bank of Wisconsin, Inc. | Biologics | 01/12/2023 | No Action Indicated (NAI) |
| Mentoring Positives, Inc. | Food/Cosmetics | 10/19/2023 | No Action Indicated (NAI) |
| Merit CRO, Inc. | Devices | 04/28/2023 | Voluntary Action Indicated (VAI) |
| Midwest Refrigerated Services, LLC | Food/Cosmetics | 07/11/2023 | No Action Indicated (NAI) |
| Midwestern Bio-Agent Holdings, LLC | Veterinary | 01/19/2023 | No Action Indicated (NAI) |
| NorthStar Medical Radioisotopes, LLC | Drugs | 09/08/2023 | No Action Indicated (NAI) |
| Phillips Distributing Corporation | Food/Cosmetics | 07/11/2023 | No Action Indicated (NAI) |
| Quincy Bioscience Holding Company, Inc. | Food/Cosmetics | 03/16/2023 | Voluntary Action Indicated (VAI) |
| Quincy Bioscience Holding Company, Inc. | Food/Cosmetics | 03/16/2023 | No Action Indicated (NAI) |
| RanDan Agri- Service Corporation, Inc. | Veterinary | 01/31/2023 | No Action Indicated (NAI) |
| Reciprocal Labs Corporation | Devices | 08/02/2023 | Voluntary Action Indicated (VAI) |
| Richard Wolf Trucking, Inc. | Food/Cosmetics | 01/11/2023 | No Action Indicated (NAI) |
| Spectrum Brands, Inc. | Devices | 08/04/2023 | No Action Indicated (NAI) |
| UW Provision Company, Inc. | Food/Cosmetics | 01/11/2023 | No Action Indicated (NAI) |
| University of Wisconsin System Radiopharmaceutical Production Facility | Drugs | 09/07/2023 | Voluntary Action Indicated (VAI) |
| Urban Ministry | Food/Cosmetics | 02/15/2023 | No Action Indicated (NAI) |
| Visionary Medical Supplies, Inc. | Devices | 06/29/2023 | No Action Indicated (NAI) |
| Wagner Dairy Operations, LLC | Veterinary | 12/08/2023 | Voluntary Action Indicated (VAI) |
| Wisconsin Fertility Institute | Biologics | 11/16/2023 | No Action Indicated (NAI) |
| Ziegler Dairy Farm, Inc. | Veterinary | 02/10/2023 | No Action Indicated (NAI) |
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