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 23.1% increase over 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 Devices and Food and Cosmetics sectors. The second most common type of company inspected worked in the Biologics sector.
There were 10 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (62.5%). Six should take voluntary action to correct their management operations (37.5%).
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 |
|---|---|---|---|
| 3D Medical Manufacturing, Inc. | Devices | 06/23/2023 | Voluntary Action Indicated (VAI) |
| Biomedical Regenerative GF, LLC | Devices | 05/30/2023 | Voluntary Action Indicated (VAI) |
| Export Guatemala, Corp. | Food and Cosmetics | 06/14/2023 | Voluntary Action Indicated (VAI) |
| Faico Medical, LLC | Devices | 05/02/2023 | Voluntary Action Indicated (VAI) |
| Gemini Medical Technologies, LLC | Devices | 04/21/2023 | No Action Indicated (NAI) |
| Micro Tool Engineering, Inc. | Devices | 05/22/2023 | No Action Indicated (NAI) |
| NutraMedix, LLC | Food and Cosmetics | 04/25/2023 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 05/10/2023 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 05/04/2023 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 04/28/2023 | No Action Indicated (NAI) |
| Ray's Heritage, LLC | Food and Cosmetics | 04/03/2023 | No Action Indicated (NAI) |
| Redcon 1 | Food and Cosmetics | 06/26/2023 | Voluntary Action Indicated (VAI) |
| Republic Spine, LLC | Devices | 04/03/2023 | No Action Indicated (NAI) |
| South Florida Institute for Reproductive Medicine | Biologics | 04/06/2023 | No Action Indicated (NAI) |
| St. Clement Estate Partners, Inc. | Food and Cosmetics | 04/25/2023 | Voluntary Action Indicated (VAI) |
| Wildflower Granola, LLC | Food and Cosmetics | 06/12/2023 | No Action Indicated (NAI) |
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