Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 50% decrease from the number of companies inspected in the previous year, when eight companies were inspected through eight inspections.
Most of the companies inspected were involved in the Biologics sector. The second most common type of company inspected in the time period worked in the Devices sector.
There was one company in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions. Two 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 |
---|---|---|---|
American Red Cross | Biologics | 09/07/2023 | Voluntary Action Indicated (VAI) |
Contour Healer, LLC | Devices | 09/15/2023 | Voluntary Action Indicated (VAI) |
LifeNet Health | Biologics | 03/01/2023 | No Action Indicated (NAI) |
The New Hope Center For Reproductive Medicine | Biologics | 01/20/2023 | Official Action Indicated (OAI) |