Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is a 60% increase over the number of companies inspected in the previous year, when 25 companies were inspected through 25 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 24 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (60%). 15 should take voluntary action to correct the organization's management operations (37.5%). Additionally, one company had to take regulatory and/or administrative actions (2.5%).
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 |
|---|---|---|---|
| Alani Nutrition | Food/Cosmetics | 07/19/2023 | Voluntary Action Indicated (VAI) |
| Aptis Medical, LLC | Devices | 07/11/2023 | No Action Indicated (NAI) |
| Botanical Processing | Food/Cosmetics | 09/29/2023 | Voluntary Action Indicated (VAI) |
| CS Health, LLC | Food/Cosmetics | 02/23/2023 | Voluntary Action Indicated (VAI) |
| Caudill Sprouting, LLC. | Food/Cosmetics | 01/13/2023 | Voluntary Action Indicated (VAI) |
| Creations Gardens, Inc. | Food/Cosmetics | 11/07/2023 | No Action Indicated (NAI) |
| DRE Medical Group, Inc. | Devices | 05/19/2023 | Voluntary Action Indicated (VAI) |
| Dawn Food Products, Inc. | Food/Cosmetics | 12/14/2023 | No Action Indicated (NAI) |
| Delta Air Lines, Inc. | Food/Cosmetics | 08/29/2023 | No Action Indicated (NAI) |
| Dental Choice Holdings, LLC | Devices | 10/20/2023 | No Action Indicated (NAI) |
| Desserts by Helen, Inc. | Food/Cosmetics | 03/13/2023 | Official Action Indicated (OAI) |
| Don A. Stevens, M.D. | Drugs | 04/13/2023 | Voluntary Action Indicated (VAI) |
| Epic, LLC | Veterinary | 10/26/2023 | No Action Indicated (NAI) |
| Eurest Dining Services | Food/Cosmetics | 02/08/2023 | Voluntary Action Indicated (VAI) |
| Feeders Supply Company, LLC | Veterinary | 07/27/2023 | No Action Indicated (NAI) |
| FerValue USA, LLC | Food/Cosmetics | 08/29/2023 | No Action Indicated (NAI) |
| Happy Bear, LLC | Food/Cosmetics | 09/07/2023 | No Action Indicated (NAI) |
| Hilco, LLC | Food/Cosmetics | 02/03/2023 | Voluntary Action Indicated (VAI) |
| Ivy Technology, LLC | Devices | 02/23/2023 | No Action Indicated (NAI) |
| James W. Sublett, M.D. | Biologics | 10/13/2023 | No Action Indicated (NAI) |
| John Meyer, M.D. | Drugs | 02/14/2023 | No Action Indicated (NAI) |
| KLEB, Inc. | Biologics | 08/24/2023 | No Action Indicated (NAI) |
| Kentucky Blood Center, Inc. | Biologics | 02/17/2023 | No Action Indicated (NAI) |
| Kentucky State Fair Board | Veterinary | 09/01/2023 | No Action Indicated (NAI) |
| Louisville Reproductive Center | Biologics | 08/22/2023 | Voluntary Action Indicated (VAI) |
| Med-Dyne, Inc. | Devices | 01/30/2023 | Voluntary Action Indicated (VAI) |
| Octapharma Plasma, Inc. | Biologics | 12/07/2023 | No Action Indicated (NAI) |
| PBG Enterprises, LLC. | Food/Cosmetics | 10/02/2023 | No Action Indicated (NAI) |
| Pretzel Baker, LLC | Food/Cosmetics | 08/22/2023 | No Action Indicated (NAI) |
| Rosa De Oro Bakery, LLC | Food/Cosmetics | 08/23/2023 | Voluntary Action Indicated (VAI) |
| San Francisco Bay Brands, Inc. | Veterinary | 08/23/2023 | No Action Indicated (NAI) |
| Shuckmans Fish Company & Smokery, Inc. | Food/Cosmetics | 06/08/2023 | Voluntary Action Indicated (VAI) |
| Stanley Brothers, Inc. | Food/Cosmetics | 09/06/2023 | Voluntary Action Indicated (VAI) |
| The Horton Fruit Company, Inc. | Food/Cosmetics | 09/07/2023 | Voluntary Action Indicated (VAI) |
| Thorn BioScience, LLC | Veterinary | 05/26/2023 | Voluntary Action Indicated (VAI) |
| UPS Supply Chain Solutions | Devices | 07/20/2023 | No Action Indicated (NAI) |
| UPS Supply Chain Solutions | Devices | 07/21/2023 | No Action Indicated (NAI) |
| UPS Supply Chain Solutions, Inc. | Devices | 07/24/2023 | No Action Indicated (NAI) |
| US WorldMeds, LLC | Drugs | 02/09/2023 | No Action Indicated (NAI) |
| Unifi Aviation - Delta, LLC | Food/Cosmetics | 08/29/2023 | No Action Indicated (NAI) |
| White Castle Distributing, LLC | Food/Cosmetics | 07/26/2023 | No Action Indicated (NAI) |
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