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 150% increase over the number of companies inspected in the previous year, when two companies were inspected through two inspections.
Most of the companies inspected were involved in the Drugs and Tobacco sectors. The second most common type of company inspected in the time period worked in the Biologics sector.
There were four companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct the organization's management operations.
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 |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Drugs | 06/13/2023 | Voluntary Action Indicated (VAI) |
| Merck Sharp & Dohme, LLC | Biologics | 11/16/2023 | No Action Indicated (NAI) |
| Microbac Laboratories, Inc. | Drugs | 12/06/2023 | No Action Indicated (NAI) |
| North Carolina Tobacco Manufacturing, LLC | Tobacco | 05/10/2023 | No Action Indicated (NAI) |
| Wind River Tobacco Company, LLC | Tobacco | 05/25/2023 | No Action Indicated (NAI) |
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