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 15.8% decrease from the number of companies inspected in the previous year, when 19 companies were inspected through 19 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 12 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (75%). Four should take voluntary action to correct the organization's management operations (25%).
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 |
|---|---|---|---|
| AVT Natural Products Limited | Food/Cosmetics | 10/24/2023 | No Action Indicated (NAI) |
| DT Water, LLC | Food/Cosmetics | 01/20/2023 | No Action Indicated (NAI) |
| EmCyte Corporation | Devices | 11/15/2023 | Voluntary Action Indicated (VAI) |
| Jimmy's Java | Food/Cosmetics | 10/31/2023 | No Action Indicated (NAI) |
| KSG Trade Company | Food/Cosmetics | 03/02/2023 | Voluntary Action Indicated (VAI) |
| Lee Memorial Health System - Donor Center | Biologics | 07/31/2023 | No Action Indicated (NAI) |
| Natural Health Partners, LLC | Food/Cosmetics | 10/17/2023 | No Action Indicated (NAI) |
| Octapharma Plasma, Inc. | Biologics | 08/02/2023 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 04/21/2023 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 04/20/2023 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 04/20/2023 | No Action Indicated (NAI) |
| Plasma, Inc., BPC | Biologics | 08/04/2023 | No Action Indicated (NAI) |
| Pro Med Instruments, Inc. | Devices | 02/15/2023 | Voluntary Action Indicated (VAI) |
| Skeletal Dynamics Strategic Manufacturing | Devices | 11/30/2023 | No Action Indicated (NAI) |
| Southwest Florida Fertility Center, P. A. | Biologics | 03/08/2023 | Voluntary Action Indicated (VAI) |
| The Fine Cheese Company, LLC | Food/Cosmetics | 06/30/2023 | No Action Indicated (NAI) |
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