James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 29.4% increase over the number of companies inspected in the previous year, when 17 companies were inspected through 17 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 Drugs sector.
There were 13 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (59.1%). Eight should take voluntary action to correct the organization's management operations (36.4%). Additionally, one company had to take regulatory and/or administrative actions (4.5%).
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 |
|---|---|---|---|
| Aaron L. Ellenbogen, D. O. | Drugs | 11/16/2023 | No Action Indicated (NAI) |
| Baker's Best Health Products, Inc. | Food/Cosmetics | 05/22/2023 | No Action Indicated (NAI) |
| Beaumont Hospital | Biologics | 04/14/2023 | No Action Indicated (NAI) |
| CSL Plasma, Inc. | Biologics | 06/27/2023 | No Action Indicated (NAI) |
| Future Pak | Food/Cosmetics | 06/09/2023 | No Action Indicated (NAI) |
| Future Pak, Ltd. | Food/Cosmetics | 01/18/2023 | Voluntary Action Indicated (VAI) |
| Future Pak, Ltd. | Food/Cosmetics | 01/18/2023 | Voluntary Action Indicated (VAI) |
| Garden Fresh Gourmet, LLC | Food/Cosmetics | 04/12/2023 | Voluntary Action Indicated (VAI) |
| Gemini Import Export, LLC | Food/Cosmetics | 01/10/2023 | Voluntary Action Indicated (VAI) |
| Guernsey Farms Dairy Stores, Inc. | Food/Cosmetics | 07/26/2023 | No Action Indicated (NAI) |
| Healthy Dogma, LLC | Veterinary | 04/05/2023 | No Action Indicated (NAI) |
| Jag World Wide Imports | Food/Cosmetics | 06/26/2023 | No Action Indicated (NAI) |
| Karma Spices and Trading Company, LLC | Food/Cosmetics | 04/11/2023 | No Action Indicated (NAI) |
| LA Vie Import & Export | Food/Cosmetics | 02/26/2023 | Voluntary Action Indicated (VAI) |
| LXR Biotech | Drugs | 01/20/2023 | Official Action Indicated (OAI) |
| LXR Biotech | Food/Cosmetics | 02/15/2023 | No Action Indicated (NAI) |
| La Vie Import And Export | Food/Cosmetics | 02/26/2023 | Voluntary Action Indicated (VAI) |
| MI Hop Alliance, LLC | Food/Cosmetics | 09/11/2023 | No Action Indicated (NAI) |
| Moghul Foods, LLC | Food/Cosmetics | 05/30/2023 | Voluntary Action Indicated (VAI) |
| Nayana S. Dekhne, M.D. | Devices | 07/20/2023 | No Action Indicated (NAI) |
| Ocuphire Pharma, Inc. | Drugs | 06/29/2023 | No Action Indicated (NAI) |
| PAR Sterile Products, LLC | Drugs | 04/14/2023 | Voluntary Action Indicated (VAI) |
| Spintech, Inc. | Devices | 12/14/2023 | No Action Indicated (NAI) |
Alerts Sign-up