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 52.9% decrease from the number of companies inspected in the previous year, when 17 companies were inspected through 17 inspections.
Most of the companies inspected were involved in the Devices sector. The second most common type of company inspected in the time period worked in the Drugs and Biologics sectors.
There were five companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions. Three 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 |
---|---|---|---|
Barksdale Dental Laboratory, Inc. | Devices | 08/01/2023 | Voluntary Action Indicated (VAI) |
Letco Medical, LLC | Drugs | 09/29/2023 | Voluntary Action Indicated (VAI) |
Lifesouth Community Blood Centers, Inc. | Biologics | 06/14/2023 | No Action Indicated (NAI) |
Lifesouth Community Blood Centers, Inc. | Biologics | 11/08/2023 | No Action Indicated (NAI) |
Oral Arts Dental Laboratories, Inc. | Devices | 08/04/2023 | Voluntary Action Indicated (VAI) |
Saputo Dairy Foods USA, LLC | Food/Cosmetics | 06/14/2023 | No Action Indicated (NAI) |
Structure Medical, LLC | Devices | 07/17/2023 | No Action Indicated (NAI) |
TriRx Huntsville Pharmaceutical Services, LLC | Drugs | 08/11/2023 | No Action Indicated (NAI) |