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 30% increase over the number of companies inspected in the previous year, when 10 companies received 10 inspections.
Most of the companies inspected at the time were involved in the Devices sector. The second most common type of company inspected period worked in the Biologics and Food and Cosmetics sectors.
There were seven companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (53.8%). Six should take voluntary action to correct the organization's management operations (46.2%).
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 |
|---|---|---|---|
| Benz Research And Development Corporation | Devices | 02/28/2024 | No Action Indicated (NAI) |
| Black Pearl Vision | Devices | 04/11/2024 | Voluntary Action Indicated (VAI) |
| Blue Creek Produce, LLC | Food and Cosmetics | 06/06/2024 | No Action Indicated (NAI) |
| Fertility Center and Applied Genetics of Florida | Biologics | 05/13/2024 | No Action Indicated (NAI) |
| Lumina Health Products, Inc. | Food and Cosmetics | 12/09/2024 | No Action Indicated (NAI) |
| Natural Immunogenics, Corp. | Drugs | 04/18/2024 | Voluntary Action Indicated (VAI) |
| Natural Immunogenics, Corp. | Food and Cosmetics | 06/14/2024 | No Action Indicated (NAI) |
| Nature's Rite, LLC | Food and Cosmetics | 04/10/2024 | Voluntary Action Indicated (VAI) |
| OneBlood, Inc. | Biologics | 05/10/2024 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 05/07/2024 | No Action Indicated (NAI) |
| Sarasota Medical Products, Inc. | Devices | 09/12/2024 | Voluntary Action Indicated (VAI) |
| SpecialEyes, LLC | Devices | 03/28/2024 | Voluntary Action Indicated (VAI) |
| Suncoast Communities Blood Bank, Inc. | Biologics | 05/08/2024 | No Action Indicated (NAI) |
| Ziptek, LLC | Devices | 05/22/2024 | Voluntary Action Indicated (VAI) |
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