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 1.9% decrease from the number of companies inspected in the previous year, when 53 companies were inspected through 55 inspections.
Most of the companies inspected were involved in the Food/Cosmetics and Devices sectors. The second most common type of company inspected in the time period worked in the Biologics sector.
There were 32 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (61.5%). 18 should take voluntary action to correct the organization's management operations (34.6%). Additionally, two companies had to take regulatory and/or administrative actions (3.8%).
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) |
| ADMA Biologics, Inc. | Biologics | 09/20/2023 | No Action Indicated (NAI) |
| Air-Matt, Inc. | Devices | 02/02/2023 | No Action Indicated (NAI) |
| Allied Pharmacy Products., Inc. | Devices | 01/10/2023 | Voluntary Action Indicated (VAI) |
| Arcadlab, LLC | Devices | 09/01/2023 | Voluntary Action Indicated (VAI) |
| Arthomed, LLC. | Biologics | 01/25/2023 | No Action Indicated (NAI) |
| Bing Innovations, LLC | Devices | 10/17/2023 | Voluntary Action Indicated (VAI) |
| Biomedical Regenerative GF, LLC | Devices | 05/30/2023 | Voluntary Action Indicated (VAI) |
| Boca Fertility | Biologics | 11/01/2023 | Voluntary Action Indicated (VAI) |
| Burck Oil Company, Inc. | Food/Cosmetics | 02/14/2023 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 10/04/2023 | No Action Indicated (NAI) |
| Classical Insights, LLC | Food/Cosmetics | 01/24/2023 | Voluntary Action Indicated (VAI) |
| Cosmetic Solutions, LLC | Drugs | 09/22/2023 | Official Action Indicated (OAI) |
| E5 Pharma, LLC | Drugs | 02/17/2023 | Voluntary Action Indicated (VAI) |
| Elevate Oral Care | Devices | 09/07/2023 | No Action Indicated (NAI) |
| Export Guatemala, Corp. | Food/Cosmetics | 06/14/2023 | Voluntary Action Indicated (VAI) |
| Faico Medical, LLC | Devices | 05/02/2023 | Voluntary Action Indicated (VAI) |
| Foods USA, Inc. | Food/Cosmetics | 10/06/2023 | Voluntary Action Indicated (VAI) |
| Fresh Start Produce Sales, Inc. | Food/Cosmetics | 10/16/2023 | Voluntary Action Indicated (VAI) |
| Gelato Petrini, LLC | Food/Cosmetics | 02/07/2023 | No Action Indicated (NAI) |
| Gemini Medical Technologies, LLC | Devices | 04/21/2023 | No Action Indicated (NAI) |
| Hoffman's Commercial Group, Inc. | Food/Cosmetics | 07/24/2023 | No Action Indicated (NAI) |
| Kenneth R. Beer, M.D. | Devices | 07/14/2023 | No Action Indicated (NAI) |
| Mary Susan Baker, DVM | Veterinary | 10/18/2023 | No Action Indicated (NAI) |
| Micro Tool Engineering, Inc. | Devices | 05/22/2023 | No Action Indicated (NAI) |
| NutraMedix, LLC | Food/Cosmetics | 04/25/2023 | No Action Indicated (NAI) |
| Octapharma Plasma, Inc. | Biologics | 03/16/2023 | No Action Indicated (NAI) |
| OneBlood, Inc. | Biologics | 10/11/2023 | 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) |
| Organic Supply, LLC | Food/Cosmetics | 01/18/2023 | No Action Indicated (NAI) |
| Pangea Growers Group, LLC | Food/Cosmetics | 11/14/2023 | Voluntary Action Indicated (VAI) |
| Peterson Dental Laboratory, Inc. | Devices | 03/13/2023 | No Action Indicated (NAI) |
| Polcz Fertility Lab, LLC | Biologics | 11/14/2023 | No Action Indicated (NAI) |
| Products By O2, Inc. | Drugs | 10/23/2023 | Official Action Indicated (OAI) |
| RGF Environmental Group, Inc. | Devices | 11/30/2023 | No Action Indicated (NAI) |
| Ray's Heritage, LLC | Food/Cosmetics | 04/03/2023 | No Action Indicated (NAI) |
| Redcon 1 | Food/Cosmetics | 06/26/2023 | Voluntary Action Indicated (VAI) |
| Republic Spine, LLC | Devices | 04/03/2023 | No Action Indicated (NAI) |
| Samuel N. Lederman, M.D. | Drugs | 07/21/2023 | No Action Indicated (NAI) |
| Signature Flight Support PBI, LLC. | Food/Cosmetics | 10/16/2023 | No Action Indicated (NAI) |
| South Florida Institute for Reproductive Medicine | Biologics | 04/06/2023 | No Action Indicated (NAI) |
| Specialty Food Distributors, Inc. | Food/Cosmetics | 01/30/2023 | No Action Indicated (NAI) |
| St. Clement Estate Partners, Inc. | Food/Cosmetics | 04/25/2023 | Voluntary Action Indicated (VAI) |
| Stingray Surgical Products, LLC | Devices | 02/09/2023 | Voluntary Action Indicated (VAI) |
| Tenet Good Samaritan Medical Center | Biologics | 12/05/2023 | No Action Indicated (NAI) |
| The Pyure Company, Inc. | Devices | 01/20/2023 | Voluntary Action Indicated (VAI) |
| VapoCoolShot, Inc. | Devices | 10/26/2023 | Voluntary Action Indicated (VAI) |
| Veterans Affairs Medical Center - WPB | Biologics | 12/06/2023 | No Action Indicated (NAI) |
| Walgreen Company | Food/Cosmetics | 11/14/2023 | No Action Indicated (NAI) |
| Walgreen Company | Veterinary | 11/14/2023 | No Action Indicated (NAI) |
| Wildflower Granola, LLC | Food/Cosmetics | 06/12/2023 | No Action Indicated (NAI) |
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