Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 54.5% decrease from the number of companies inspected in the previous quarter, when 11 companies received 12 inspections.
Most of the companies inspected at the time were involved in the Biologics and Drugs sectors. The second most common type of company inspected worked in the Food and Cosmetics sector.
There were three companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Two should take voluntary action to correct their 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 |
---|---|---|---|
American Red Cross Blood Services | Biologics | 10/16/2023 | Voluntary Action Indicated (VAI) |
Avioq, Inc. | Biologics | 12/05/2023 | Voluntary Action Indicated (VAI) |
Chapel Hill Creamery, LLC | Food and Cosmetics | 11/27/2023 | No Action Indicated (NAI) |
Edwin H. Kim, M.D. | Drugs | 11/08/2023 | No Action Indicated (NAI) |
Syneos Health | Drugs | 12/13/2023 | No Action Indicated (NAI) |