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 25% increase over the number of companies inspected in the previous quarter, when four companies received four inspections.
Most of the companies inspected at the time were involved in the Devices and Biologics sectors. The second most common type of company inspected worked in the Veterinary sector.
There were three companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Two should take voluntary action to correct their management operations.
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 |
|---|---|---|---|
| Harvest Sherwood Food Distributers, Inc. | Veterinary | 09/10/2024 | No Action Indicated (NAI) |
| Newman Medical | Devices | 09/25/2024 | Voluntary Action Indicated (VAI) |
| University Of Colorado Hospital Clinical Laboratory | Biologics | 08/01/2024 | No Action Indicated (NAI) |
| University of Colorado Hospital Authority | Biologics | 07/30/2024 | No Action Indicated (NAI) |
| WalkMed, LLC | Devices | 09/13/2024 | Voluntary Action Indicated (VAI) |
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