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 16.7% increase over the number of companies inspected in the previous year, when 18 companies were inspected through 18 inspections.
Most of the companies inspected were involved in the Devices sector. The second most common type of company inspected in the time period worked in the Food/Cosmetics sector.
There were 15 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (71.4%). Six should take voluntary action to correct the organization's management operations (28.6%).
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 |
|---|---|---|---|
| ARCH-Quakertown | Devices | 01/13/2023 | No Action Indicated (NAI) |
| Advanced Verterbral Solutions | Devices | 05/26/2023 | No Action Indicated (NAI) |
| American Breadcrumb Company, LLC | Food/Cosmetics | 04/14/2023 | Voluntary Action Indicated (VAI) |
| Axial Medical | Devices | 03/10/2023 | No Action Indicated (NAI) |
| Coco Blast, LLC | Food/Cosmetics | 05/19/2023 | No Action Indicated (NAI) |
| DIJAS Foods DIstribution, Inc. | Food/Cosmetics | 09/13/2023 | Voluntary Action Indicated (VAI) |
| DIJAS Foods DIstribution, Inc. | Veterinary | 09/13/2023 | No Action Indicated (NAI) |
| Knauss Foods, Inc. | Food/Cosmetics | 04/28/2023 | No Action Indicated (NAI) |
| Knauss Foods, Inc. | Veterinary | 04/28/2023 | No Action Indicated (NAI) |
| Mars Fishcare North America, Inc. | Veterinary | 04/07/2023 | Voluntary Action Indicated (VAI) |
| Medimpex United, Inc. | Devices | 10/03/2023 | No Action Indicated (NAI) |
| Mega Food International | Food/Cosmetics | 04/13/2023 | No Action Indicated (NAI) |
| Morton Salt - Fairless Hills, Inc. | Veterinary | 12/05/2023 | No Action Indicated (NAI) |
| Oricare, Inc. | Devices | 05/03/2023 | No Action Indicated (NAI) |
| PEL Healthcare, LLC | Drugs | 01/13/2023 | Voluntary Action Indicated (VAI) |
| Particle Size Technology, Inc. | Drugs | 11/16/2023 | Voluntary Action Indicated (VAI) |
| Powdersize, LLC | Drugs | 07/14/2023 | No Action Indicated (NAI) |
| Pulse Technologies, Inc. | Devices | 09/21/2023 | No Action Indicated (NAI) |
| Reproductive Medicine Associates Of Philadelphia, P.C. | Biologics | 01/24/2023 | No Action Indicated (NAI) |
| Roxy & Honey, LLC | Veterinary | 05/06/2023 | No Action Indicated (NAI) |
| SigmaPharm Laboratories, LLC | Drugs | 02/13/2023 | No Action Indicated (NAI) |
| Sweet Note Bakery, Inc. | Food/Cosmetics | 09/13/2023 | No Action Indicated (NAI) |
| Thrombolex, Inc. | Devices | 03/30/2023 | Voluntary Action Indicated (VAI) |
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