DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 4.8% increase over the number of companies inspected in the previous quarter, when 21 companies received 33 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 worked in the Devices sector.
There were 17 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (77.3%). Four should take voluntary action to correct the organization's management operations (18.2%). 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 |
|---|---|---|---|
| Children's Healthcare IRB #1 | Biologics | 02/03/2023 | Voluntary Action Indicated (VAI) |
| Children's Healthcare IRB #1 | Devices | 02/03/2023 | Voluntary Action Indicated (VAI) |
| Children's Healthcare IRB #1 | Drugs | 02/03/2023 | Voluntary Action Indicated (VAI) |
| Coloplast Manufacturing US, LLC | Devices | 01/20/2023 | No Action Indicated (NAI) |
| Daily Medical Products, Inc. | Devices | 03/21/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/03/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/03/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/12/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/12/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/17/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 01/19/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 02/13/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 02/21/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 02/21/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 03/08/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 03/08/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 03/24/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 03/27/2023 | No Action Indicated (NAI) |
| Delta Air Lines | Food and Cosmetics | 03/27/2023 | No Action Indicated (NAI) |
| E. A. Sween | Food and Cosmetics | 03/30/2023 | No Action Indicated (NAI) |
| East Wholesale, LLC | Food and Cosmetics | 03/14/2023 | Voluntary Action Indicated (VAI) |
| Emily N. Prendergast, M.D. | Drugs | 03/03/2023 | No Action Indicated (NAI) |
| Funky Chunky, LLC | Food and Cosmetics | 02/02/2023 | Official Action Indicated (OAI) |
| Great Dog Company, LLC | Veterinary | 01/26/2023 | No Action Indicated (NAI) |
| Hamel Maple Syrup Company, Inc. | Food and Cosmetics | 03/29/2023 | No Action Indicated (NAI) |
| Hopkins Activity Center | Food and Cosmetics | 02/08/2023 | No Action Indicated (NAI) |
| Kasa Family Foods, LLC | Food and Cosmetics | 02/27/2023 | No Action Indicated (NAI) |
| LC Finns, LLC | Food and Cosmetics | 03/10/2023 | No Action Indicated (NAI) |
| NAMSA | Devices | 02/08/2023 | No Action Indicated (NAI) |
| Nordson Medical MN, LLC | Devices | 03/24/2023 | No Action Indicated (NAI) |
| Pohl Food Service, Inc. | Food and Cosmetics | 01/23/2023 | No Action Indicated (NAI) |
| Return Management Services, Inc. | Food and Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
| Smiths Medical ASD, Inc. | Devices | 03/03/2023 | Voluntary Action Indicated (VAI) |
| Sofia's Cookies, Inc. | Food and Cosmetics | 01/13/2023 | No Action Indicated (NAI) |
| Taiyo International, Inc. | Food and Cosmetics | 02/28/2023 | No Action Indicated (NAI) |
| The Twisted Shrub | Food and Cosmetics | 03/29/2023 | Voluntary Action Indicated (VAI) |
| Zinpro Animal Corporation, Inc. | Veterinary | 03/24/2023 | No Action Indicated (NAI) |
Alerts Sign-up