Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is a 20.8% decrease from the number of companies inspected in the previous year, when 48 companies received 53 inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics sector. The second most common type of company inspected period worked in the Drugs and Devices sectors.
There were 28 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (73.7%). Nine should take voluntary action to correct the organization's management operations (23.7%). Additionally, one company had to take regulatory and/or administrative actions (2.6%).
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.
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 |
|---|---|---|---|
| AbbVie, Inc. | Drugs | 06/18/2024 | Voluntary Action Indicated (VAI) |
| AbbVie, Inc. | Drugs | 04/19/2024 | No Action Indicated (NAI) |
| Arxium, Inc. | Devices | 04/01/2024 | Voluntary Action Indicated (VAI) |
| Baxter Healthcare Corporation | Drugs | 08/01/2024 | Official Action Indicated (OAI) |
| Baxter Healthcare Corporation | Drugs | 02/06/2024 | No Action Indicated (NAI) |
| BioLife Plasma Services L. P. | Biologics | 08/22/2024 | Voluntary Action Indicated (VAI) |
| Bolke-Miller Company | Food and Cosmetics | 05/23/2024 | No Action Indicated (NAI) |
| Bolke-Miller Company | Veterinary | 05/23/2024 | No Action Indicated (NAI) |
| Bolke-Miller Company | Food and Cosmetics | 05/23/2024 | No Action Indicated (NAI) |
| Bolke-Miller Company | Veterinary | 05/23/2024 | No Action Indicated (NAI) |
| Bozic'S Imports & Wholesale Liquors | Food and Cosmetics | 08/26/2024 | No Action Indicated (NAI) |
| CTCA @ Midwestern Regional Medical Center | Biologics | 12/17/2024 | No Action Indicated (NAI) |
| Flextronics International USA, Inc. | Devices | 09/06/2024 | No Action Indicated (NAI) |
| Florov Pipes | Tobacco | 01/03/2024 | No Action Indicated (NAI) |
| Fresenius Kabi USA, LLC | Drugs | 08/27/2024 | No Action Indicated (NAI) |
| GE Healthcare, Inc. | Drugs | 03/08/2024 | Voluntary Action Indicated (VAI) |
| Graham Chemical, CORP | Food and Cosmetics | 02/21/2024 | No Action Indicated (NAI) |
| Healthcare-id, Inc. | Biologics | 07/18/2024 | Voluntary Action Indicated (VAI) |
| Highland Park Hospital | Biologics | 04/25/2024 | No Action Indicated (NAI) |
| Hospira, Inc. | Biologics | 06/07/2024 | No Action Indicated (NAI) |
| ICU Medical, Inc. | Drugs | 09/09/2024 | No Action Indicated (NAI) |
| Isomedix Operations, Inc. | Devices | 09/19/2024 | No Action Indicated (NAI) |
| Isomedix Operations, Inc. | Devices | 09/23/2024 | No Action Indicated (NAI) |
| Kalle USA, LLC | Food and Cosmetics | 08/22/2024 | No Action Indicated (NAI) |
| Long Grove Confectionery, Inc. | Food and Cosmetics | 09/05/2024 | No Action Indicated (NAI) |
| Lou Malnati's Priority Pizza, LLC | Food and Cosmetics | 04/24/2024 | No Action Indicated (NAI) |
| Lundbeck Pharmaceuticals, LLC | Drugs | 10/25/2024 | No Action Indicated (NAI) |
| Midmark Corporation | Devices | 03/14/2024 | No Action Indicated (NAI) |
| Miracapo Pizza Company, LLC | Food and Cosmetics | 07/19/2024 | Voluntary Action Indicated (VAI) |
| NM FRM Andrology Services North | Biologics | 04/02/2024 | No Action Indicated (NAI) |
| North American Herb & Spice Company, LLC, Ltd. | Food and Cosmetics | 05/07/2024 | No Action Indicated (NAI) |
| North American Herb and Spice Company, LLC, Ltd. | Food and Cosmetics | 05/13/2024 | Voluntary Action Indicated (VAI) |
| Pet Factory, Inc. | Veterinary | 09/10/2024 | No Action Indicated (NAI) |
| Quality Catering for Kids, Inc. | Food and Cosmetics | 01/16/2024 | Voluntary Action Indicated (VAI) |
| RPI Biosolutions | Biologics | 08/21/2024 | No Action Indicated (NAI) |
| Sage Products, LLC | Devices | 02/15/2024 | No Action Indicated (NAI) |
| Stericycle, Inc. | Devices | 02/12/2024 | Voluntary Action Indicated (VAI) |
| Stiglmeier Sausage Company, Inc. | Food and Cosmetics | 05/15/2024 | No Action Indicated (NAI) |
| The Popcorn Factory | Food and Cosmetics | 03/15/2024 | No Action Indicated (NAI) |
| The Popcorn Factory | Veterinary | 03/15/2024 | No Action Indicated (NAI) |
| Zenith Technical Innovations, LLC | Devices | 03/21/2024 | No Action Indicated (NAI) |
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