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 23.1% decrease from the number of companies inspected in the previous year, when 13 companies were inspected through 13 inspections.
Most of the companies inspected were involved in the Devices sector. The second most common type of company inspected in the time period worked in the Food/Cosmetics sector.
There were six companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (60%). Three should take voluntary action to correct the organization's management operations (30%). Additionally, one company had to take regulatory and/or administrative actions (10%).
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 |
|---|---|---|---|
| Allegro Coffee Company - Park Warehouse | Food/Cosmetics | 10/11/2023 | No Action Indicated (NAI) |
| Allison Medical, Inc. | Devices | 04/28/2023 | Voluntary Action Indicated (VAI) |
| Andrew J Wolfe, M.D. | Devices | 06/23/2023 | No Action Indicated (NAI) |
| Dechoker, LLC | Devices | 05/26/2023 | No Action Indicated (NAI) |
| Kenneth Cohen | Biologics | 02/10/2023 | No Action Indicated (NAI) |
| Medical Modeling, a 3D Systems Company | Devices | 09/15/2023 | No Action Indicated (NAI) |
| Orpheus Medical USA, Inc. | Devices | 02/02/2023 | No Action Indicated (NAI) |
| Osmosis, LLC | Food/Cosmetics | 01/13/2023 | Official Action Indicated (OAI) |
| School Health Front Range, Inc. | Biologics | 03/21/2023 | Voluntary Action Indicated (VAI) |
| Wild Warrior Nutrition, LLC | Food/Cosmetics | 07/14/2023 | Voluntary Action Indicated (VAI) |
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