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 12.5% decrease from the number of companies inspected in the previous quarter, when 16 companies received 16 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 six companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (42.9%). Seven should take voluntary action to correct the organization's management operations (50%). Additionally, one company had to take regulatory and/or administrative actions (7.1%).
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.
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 |
|---|---|---|---|
| AxioMed, LLC. | Devices | 01/13/2023 | Voluntary Action Indicated (VAI) |
| Azurity Pharmaceuticals, Inc. | Drugs | 03/02/2023 | No Action Indicated (NAI) |
| Barrett Technology, LLC | Devices | 03/07/2023 | Voluntary Action Indicated (VAI) |
| Candela Corporation | Devices | 01/24/2023 | Voluntary Action Indicated (VAI) |
| Conformis, Inc. | Devices | 03/09/2023 | Voluntary Action Indicated (VAI) |
| East West Imports, Inc. | Food and Cosmetics | 02/01/2023 | Voluntary Action Indicated (VAI) |
| Hemedex, Inc. | Devices | 02/17/2023 | No Action Indicated (NAI) |
| Italian Ready Meals | Food and Cosmetics | 03/17/2023 | No Action Indicated (NAI) |
| Karyopharm Therapeutics, Inc. | Drugs | 03/15/2023 | No Action Indicated (NAI) |
| Lineage Logistics | Food and Cosmetics | 01/17/2023 | No Action Indicated (NAI) |
| Navada Imports | Food and Cosmetics | 01/10/2023 | Voluntary Action Indicated (VAI) |
| Safecor Health, LLC | Drugs | 03/16/2023 | Official Action Indicated (OAI) |
| Victoria Gourmet, Inc. | Food and Cosmetics | 01/27/2023 | No Action Indicated (NAI) |
| dnata US Inflight Catering, LLC | Food and Cosmetics | 01/18/2023 | Voluntary Action Indicated (VAI) |
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