Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 60% 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 Biologics sector. The second most common type of company inspected worked in the Devices sector.
There were six companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Two 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 |
|---|---|---|---|
| ClinImmune Labs-University Colorado Cord Blood Bank and Stem Cell Lab | Biologics | 09/19/2023 | No Action Indicated (NAI) |
| Lewis, Karl D., M.D. | Biologics | 08/07/2023 | Voluntary Action Indicated (VAI) |
| Medical Modeling, a 3D Systems Company | Devices | 09/15/2023 | No Action Indicated (NAI) |
| Melamed, Isaac R., M.D. | Biologics | 09/01/2023 | No Action Indicated (NAI) |
| Paragon 28, Inc. | Devices | 07/13/2023 | No Action Indicated (NAI) |
| University of Colorado-Saint Louis Cord Blood Bank | Biologics | 09/15/2023 | No Action Indicated (NAI) |
| Wright Medical Technology, Inc. | Biologics | 08/09/2023 | No Action Indicated (NAI) |
| Yoshicon, LLC | Tobacco | 08/10/2023 | Voluntary Action Indicated (VAI) |
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