Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is an 80% increase over the number of companies inspected in the previous quarter, when five companies received five inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics sector. Both the Devices and Biologics sectors sectors tied for second most common type.
There were six companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Three 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 |
---|---|---|---|
Batistini USA, LLC | Food and Cosmetics | 04/27/2023 | Voluntary Action Indicated (VAI) |
Carolon Company | Devices | 06/15/2023 | Voluntary Action Indicated (VAI) |
Combs Wholesale Produce | Food and Cosmetics | 05/16/2023 | No Action Indicated (NAI) |
CorneaGEn, Inc. | Biologics | 05/31/2023 | Voluntary Action Indicated (VAI) |
DFA Dairy Brands Fluid, LLC | Food and Cosmetics | 06/26/2023 | No Action Indicated (NAI) |
High Point Regional Health System | Biologics | 04/26/2023 | No Action Indicated (NAI) |
Krispy Kreme Doughnut | Food and Cosmetics | 06/27/2023 | No Action Indicated (NAI) |
Solutex Llc, NA | Food and Cosmetics | 04/19/2023 | No Action Indicated (NAI) |
Wake Forest University Health Sciences IRB | Devices | 06/07/2023 | No Action Indicated (NAI) |