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 200% increase over the number of companies inspected in the previous year, when six companies were inspected through six inspections.
Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Devices and Drugs sectors.
There were 12 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (66.7%). Five should take voluntary action to correct the organization's management operations (27.8%). Additionally, one company had to take regulatory and/or administrative actions (5.6%).
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 |
|---|---|---|---|
| Aqua Greens, LLC | Food/Cosmetics | 04/05/2023 | No Action Indicated (NAI) |
| BioLife Plasma Services L. P. | Biologics | 12/14/2023 | No Action Indicated (NAI) |
| BioLyte Laboratories, LLC | Drugs | 04/27/2023 | Official Action Indicated (OAI) |
| BioLyte Laboratories, LLC | Food/Cosmetics | 04/06/2023 | No Action Indicated (NAI) |
| Brenntag Great Lakes, LLC | Food/Cosmetics | 07/12/2023 | No Action Indicated (NAI) |
| Deanna S. Mitchell, M.D. | Drugs | 02/17/2023 | No Action Indicated (NAI) |
| Dennis Hammond | Devices | 06/20/2023 | Voluntary Action Indicated (VAI) |
| Gordon Food Services Clay Ave Distribution Center | Food/Cosmetics | 12/04/2023 | No Action Indicated (NAI) |
| Gourmet International, Ltd. | Food/Cosmetics | 03/27/2023 | No Action Indicated (NAI) |
| IVF Laboratories of Grand Rapids, LLC | Biologics | 04/27/2023 | Voluntary Action Indicated (VAI) |
| Manish R. Sharma, M.D. | Drugs | 07/20/2023 | No Action Indicated (NAI) |
| Medisurge, LLC. | Devices | 03/17/2023 | No Action Indicated (NAI) |
| Meijer #816 - Grand River Packaging, Inc. | Food/Cosmetics | 09/06/2023 | Voluntary Action Indicated (VAI) |
| Meijer Distribution, Inc. | Food/Cosmetics | 09/20/2023 | No Action Indicated (NAI) |
| Michigan Reproductive and IVF Center, PLLC | Biologics | 04/27/2023 | Voluntary Action Indicated (VAI) |
| Rose Technologies Company | Devices | 06/08/2023 | No Action Indicated (NAI) |
| Sixarp, LLC | Food/Cosmetics | 09/12/2023 | No Action Indicated (NAI) |
| Sreenivasa R. Chandana, Ph. D., M.D. | Drugs | 08/11/2023 | No Action Indicated (NAI) |
| SunMed Holdings, LLC | Devices | 08/30/2023 | Voluntary Action Indicated (VAI) |
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