Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is a 250% increase over the number of companies inspected in the previous month, when two companies received two inspections.
Most of the companies inspected at the time were involved in the Biologics and Food and Cosmetics sectors. The second most common type of company inspected period worked in the Devices sector.
There were five companies 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.
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| Acuity Surgical Devices, LLC | Devices | 01/27/2025 | Voluntary Action Indicated (VAI) |
| Aspire Fertility Institute Dallas | Biologics | 01/23/2025 | No Action Indicated (NAI) |
| Emanuel Distributors | Food and Cosmetics | 01/13/2025 | Voluntary Action Indicated (VAI) |
| Fertility Center of Dallas | Biologics | 01/28/2025 | No Action Indicated (NAI) |
| Gordon Food Service | Food and Cosmetics | 01/13/2025 | No Action Indicated (NAI) |
| Kevala International, LLC | Food and Cosmetics | 01/13/2025 | No Action Indicated (NAI) |
| Transplant Services Center UT Southwestern Medical Center | Biologics | 01/24/2025 | No Action Indicated (NAI) |
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