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 36.4% increase over the number of companies inspected in the previous quarter, when 11 companies received 11 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 worked in the Devices sector.
There were 10 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (66.7%). Four should take voluntary action to correct the organization's management operations (26.7%). Additionally, one company had to take regulatory and/or administrative actions (6.7%).
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 |
|---|---|---|---|
| American National Red Cross Carolinas Region | Biologics | 02/01/2023 | No Action Indicated (NAI) |
| American Red Cross | Biologics | 02/08/2023 | No Action Indicated (NAI) |
| American Sprinkle Company | Food and Cosmetics | 02/15/2023 | No Action Indicated (NAI) |
| Bakkavor Foods USA, Inc. | Food and Cosmetics | 02/24/2023 | Official Action Indicated (OAI) |
| Beat Childhood Cancer, Levine Childrens Hospital | Drugs | 02/06/2023 | No Action Indicated (NAI) |
| Distribution Technology, Inc. | Food and Cosmetics | 03/09/2023 | No Action Indicated (NAI) |
| Life Sensing Instruments, Inc. | Devices | 01/27/2023 | Voluntary Action Indicated (VAI) |
| Mad Barn USA, Inc. | Food and Cosmetics | 01/24/2023 | No Action Indicated (NAI) |
| Martin's Distribution, Inc. | Food and Cosmetics | 03/08/2023 | No Action Indicated (NAI) |
| Pennys Gourmet Foods, LLC | Food and Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
| REACT Innovations | Devices | 02/17/2023 | Voluntary Action Indicated (VAI) |
| Shebli Atrash, M.D. | Drugs | 03/16/2023 | No Action Indicated (NAI) |
| Summit Coffee Roasting Company, LLC. | Food and Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
| USA Facemask, LLC | Devices | 03/17/2023 | Voluntary Action Indicated (VAI) |
| Van Harvest Distribution, LLC. | Food and Cosmetics | 03/30/2023 | Voluntary Action Indicated (VAI) |
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