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 23.3% increase over the number of companies inspected in the previous year, when 30 companies were inspected through 30 inspections.
Most of the companies inspected were involved in the Food/Cosmetics and Biologics sectors. 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 (75.7%). Eight should take voluntary action to correct the organization's management operations (21.6%). Additionally, one company had to take regulatory and/or administrative actions (2.7%).
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 |
|---|---|---|---|
| Almased USA, Inc. | Food/Cosmetics | 11/06/2023 | No Action Indicated (NAI) |
| 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 Red Cross Blood Services Carolinas Region | Biologics | 05/03/2023 | No Action Indicated (NAI) |
| American Sprinkle Company | Food/Cosmetics | 02/15/2023 | No Action Indicated (NAI) |
| Bakkavor Foods USA, Inc. | Food/Cosmetics | 02/24/2023 | Official Action Indicated (OAI) |
| Bakkavor Foods USA, Inc. | Food/Cosmetics | 12/01/2023 | No Action Indicated (NAI) |
| Barnett International Corporation | Devices | 08/08/2023 | No Action Indicated (NAI) |
| Beat Childhood Cancer, Levine Childrens Hospital | Drugs | 02/06/2023 | No Action Indicated (NAI) |
| BioLife Plasma Services | Biologics | 08/17/2023 | No Action Indicated (NAI) |
| Birth Tissue Recovery, LLC | Biologics | 05/09/2023 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 05/25/2023 | No Action Indicated (NAI) |
| Canteen Charlotte | Food/Cosmetics | 05/04/2023 | No Action Indicated (NAI) |
| Charlotte Mecklenburg Hospital Authority | Biologics | 05/18/2023 | Voluntary Action Indicated (VAI) |
| DEXIOS Services, LLC | Devices | 07/21/2023 | No Action Indicated (NAI) |
| Distribution Technology, Inc. | Food/Cosmetics | 03/09/2023 | No Action Indicated (NAI) |
| Emage Medical, LLC | Devices | 04/04/2023 | Voluntary Action Indicated (VAI) |
| GlobalMed Logistix, LLC | Biologics | 10/26/2023 | No Action Indicated (NAI) |
| Life Sensing Instruments, Inc. | Devices | 01/27/2023 | Voluntary Action Indicated (VAI) |
| Mad Barn USA, Inc. | Food/Cosmetics | 01/24/2023 | No Action Indicated (NAI) |
| Madrona Specialty Foods, LLC | Food/Cosmetics | 12/06/2023 | No Action Indicated (NAI) |
| Martin's Distribution, Inc. | Food/Cosmetics | 03/08/2023 | No Action Indicated (NAI) |
| Mohammad R. Bolouri, M.D. | Drugs | 04/04/2023 | No Action Indicated (NAI) |
| NoDa Brewing Company | Food/Cosmetics | 06/28/2023 | No Action Indicated (NAI) |
| NoDa Brewing Company | Veterinary | 06/28/2023 | No Action Indicated (NAI) |
| Octapharma Plasma, Inc. | Biologics | 07/21/2023 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 10/26/2023 | No Action Indicated (NAI) |
| Orange Bakery, Inc. | Food/Cosmetics | 05/18/2023 | Voluntary Action Indicated (VAI) |
| Pennys Gourmet Foods, LLC | Food/Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
| REACT Innovations | Devices | 02/17/2023 | Voluntary Action Indicated (VAI) |
| Reproductive Endocrinology Associates of Charlotte | Biologics | 05/11/2023 | No Action Indicated (NAI) |
| Reproductive Specialists of the Carolinas | Biologics | 05/04/2023 | No Action Indicated (NAI) |
| Salvin Dental Specialties, Inc. | Biologics | 10/27/2023 | No Action Indicated (NAI) |
| Shebli Atrash, M.D. | Drugs | 03/16/2023 | No Action Indicated (NAI) |
| Sol International, LLC | Food/Cosmetics | 11/08/2023 | Voluntary Action Indicated (VAI) |
| Summit Coffee Roasting Company, LLC. | Food/Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
| The Program for Assisted Reproduction at Atrium Health's Carolinas Medical Center | Biologics | 05/10/2023 | No Action Indicated (NAI) |
| USA Facemask, LLC | Devices | 03/17/2023 | Voluntary Action Indicated (VAI) |
| Van Harvest Distribution, LLC. | Food/Cosmetics | 03/30/2023 | Voluntary Action Indicated (VAI) |
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