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 a 25% increase over the number of companies inspected in the previous quarter, when eight companies received eight inspections.
Most of the companies inspected at the time were involved in the Devices sector. The second most common type of company inspected worked in the Food and Cosmetics sector.
There were four companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (40%). Six should take voluntary action to correct their management operations (60%).
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 |
---|---|---|---|
Anodyne Therapy, LLC | Devices | 09/14/2023 | No Action Indicated (NAI) |
Catalent Pharma Solutions, LLC | Food and Cosmetics | 07/21/2023 | Voluntary Action Indicated (VAI) |
Eagle Labs, Inc. | Drugs | 08/24/2023 | No Action Indicated (NAI) |
Jennifer W. Leiding, M.D. | Biologics | 09/08/2023 | Voluntary Action Indicated (VAI) |
Kirk Iannone | Veterinary | 09/21/2023 | Voluntary Action Indicated (VAI) |
Lantmannen Unibake USA | Food and Cosmetics | 09/13/2023 | No Action Indicated (NAI) |
McPherson Enterprises, Inc. | Devices | 09/06/2023 | Voluntary Action Indicated (VAI) |
Peter W. Blumencranz, M.D. | Devices | 08/04/2023 | No Action Indicated (NAI) |
Sun Dental Laboratories, LLC | Devices | 09/20/2023 | Voluntary Action Indicated (VAI) |
Ultra Clean Systems, Inc. | Devices | 08/11/2023 | Voluntary Action Indicated (VAI) |