Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 15.4% decrease from the number of companies inspected in the previous quarter, when 13 companies received 13 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 Food and Cosmetics sector.
There were nine companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (81.8%). One should take voluntary action to correct the organization's management operations (9.1%). Additionally, one company had to take regulatory and/or administrative actions (9.1%).
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 |
|---|---|---|---|
| Airgas USA, LLC | Drugs | 08/15/2024 | Voluntary Action Indicated (VAI) |
| American Red Cross Blood Services - Southwest Region | Biologics | 08/27/2024 | No Action Indicated (NAI) |
| Aspire Fertility | Biologics | 08/28/2024 | No Action Indicated (NAI) |
| CHI St. Lukes Health The Woodlands Hospital | Biologics | 08/29/2024 | No Action Indicated (NAI) |
| Cheesemakers, Inc. | Food and Cosmetics | 08/14/2024 | No Action Indicated (NAI) |
| Gotera, Inc. | Food and Cosmetics | 09/06/2024 | No Action Indicated (NAI) |
| Gulf Coast Regional Blood Center | Biologics | 07/17/2024 | No Action Indicated (NAI) |
| Gulf Coast Regional Blood Center at Westchase | Biologics | 09/12/2024 | No Action Indicated (NAI) |
| Lifegift Organ Donation Center | Biologics | 08/27/2024 | No Action Indicated (NAI) |
| Smithfield Direct, LLC | Food and Cosmetics | 07/17/2024 | No Action Indicated (NAI) |
| Winfull Corporation | Food and Cosmetics | 07/26/2024 | Official Action Indicated (OAI) |
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