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 63.6% decrease from the number of companies inspected in the previous quarter, when 11 companies received 11 inspections.
Most of the companies inspected at the time were involved in the Devices sector. Both the Biologics and Drugs sectors sectors tied for second most common type.
There were three companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct its 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 |
|---|---|---|---|
| Digisonics, Inc. | Devices | 08/12/2024 | No Action Indicated (NAI) |
| Indivior Manufacturing, LLC | Drugs | 07/26/2024 | Voluntary Action Indicated (VAI) |
| James P. Zidar, M.D. | Devices | 08/07/2024 | No Action Indicated (NAI) |
| Rex Hospital, Inc. | Biologics | 09/09/2024 | No Action Indicated (NAI) |
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