James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 40.9% decrease from the number of companies inspected in the previous year, when 22 companies were inspected through 22 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 Food/Cosmetics sector.
There were eight companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (61.5%). Five should take voluntary action to correct the organization's management operations (38.5%).
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 |
|---|---|---|---|
| Brazilian Pet, LLC. | Veterinary | 08/15/2023 | Voluntary Action Indicated (VAI) |
| CSL Plasma, Inc. | Biologics | 05/11/2023 | No Action Indicated (NAI) |
| Exal Foods, LLC | Food/Cosmetics | 01/06/2023 | No Action Indicated (NAI) |
| Fertility Center of Orlando | Biologics | 11/21/2023 | Voluntary Action Indicated (VAI) |
| Fortuna Group Trade, Corp. | Food/Cosmetics | 07/17/2023 | No Action Indicated (NAI) |
| Kalitec Direct, LLC | Devices | 03/02/2023 | No Action Indicated (NAI) |
| Kedplasma, LLC | Biologics | 06/26/2023 | Voluntary Action Indicated (VAI) |
| Nuline Sensors, LLC | Devices | 04/25/2023 | Voluntary Action Indicated (VAI) |
| Nutrex Research, Inc. | Food/Cosmetics | 08/11/2023 | Voluntary Action Indicated (VAI) |
| OneBlood, Inc. | Biologics | 10/16/2023 | No Action Indicated (NAI) |
| Pathen Medical, LLC | Devices | 12/13/2023 | No Action Indicated (NAI) |
| Reproductive Medicine Associates of Florida | Biologics | 06/12/2023 | No Action Indicated (NAI) |
| The Father's Table, LLC | Food/Cosmetics | 07/12/2023 | No Action Indicated (NAI) |
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