Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
This is a 37.5% increase over the number of companies inspected in the previous year, when eight companies received eight inspections.
Most of the companies inspected at the time were involved in the Devices sector. The second most common type of company inspected period worked in the Food and Cosmetics sector.
There were five companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (45.5%). Five should take voluntary action to correct the organization's management operations (45.5%). Additionally, one company had to take regulatory and/or administrative actions (9.1%).
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.
According to its website, 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.
Company Name | Area of Business | Inspection Date | Result |
---|---|---|---|
American Soy Products, Inc. | Food and Cosmetics | 08/16/2024 | Voluntary Action Indicated (VAI) |
Axiobionics, LLC | Devices | 11/22/2024 | Voluntary Action Indicated (VAI) |
Danmar Products, Inc. | Devices | 11/04/2024 | Voluntary Action Indicated (VAI) |
David P. Fivenson, M.D. | Drugs | 05/23/2024 | Voluntary Action Indicated (VAI) |
Food Gatherers, Inc. | Food and Cosmetics | 02/13/2024 | No Action Indicated (NAI) |
Green Hope, LLC | Food and Cosmetics | 03/18/2024 | Voluntary Action Indicated (VAI) |
HB Nature Stores, LLC | Veterinary | 06/04/2024 | No Action Indicated (NAI) |
MedImage, Inc. | Devices | 11/14/2024 | No Action Indicated (NAI) |
Trinity Health Ann Arbor | Biologics | 11/21/2024 | No Action Indicated (NAI) |
VA Ann Arbor Healthcare System | Biologics | 09/23/2024 | No Action Indicated (NAI) |
Xoran Technologies, LLC | Devices | 07/11/2024 | Official Action Indicated (OAI) |