Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 33.3% increase over the number of companies inspected in the previous quarter, when three companies received three inspections.
Most of the companies inspected at the time were involved in the Biologics sector. Both the Food and Cosmetics and Devices sectors sectors tied for second most common type.
There were two 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 the organization's management operations. Additionally, one company had to take regulatory and/or administrative actions.
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 |
---|---|---|---|
Kenneth Cohen | Biologics | 02/10/2023 | No Action Indicated (NAI) |
Orpheus Medical USA, Inc. | Devices | 02/02/2023 | No Action Indicated (NAI) |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Official Action Indicated (OAI) |
School Health Front Range, Inc. | Biologics | 03/21/2023 | Voluntary Action Indicated (VAI) |