Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 20% decrease from the number of companies inspected in the previous quarter, when 15 companies received 15 inspections.
Most of the companies inspected at the time were involved in the Biologics sector. The second most common type of company inspected worked in the Food and Cosmetics sector.
There were nine companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (75%). Three should take voluntary action to correct their 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 |
|---|---|---|---|
| American Red Cross Blood Services Carolinas Region | Biologics | 05/03/2023 | 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 and Cosmetics | 05/04/2023 | No Action Indicated (NAI) |
| Charlotte Mecklenburg Hospital Authority | Biologics | 05/18/2023 | Voluntary Action Indicated (VAI) |
| Emage Medical, LLC | Devices | 04/04/2023 | Voluntary Action Indicated (VAI) |
| Mohammad R. Bolouri, M.D. | Drugs | 04/04/2023 | No Action Indicated (NAI) |
| NoDa Brewing Company | Food and Cosmetics | 06/28/2023 | No Action Indicated (NAI) |
| NoDa Brewing Company | Veterinary | 06/28/2023 | No Action Indicated (NAI) |
| Orange Bakery, Inc. | Food and Cosmetics | 05/18/2023 | 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) |
| The Program for Assisted Reproduction at Atrium Health's Carolinas Medical Center | Biologics | 05/10/2023 | No Action Indicated (NAI) |
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