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% decrease from 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 Biologics sector. The second most common type of company inspected worked in the Devices sector.
There were two companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct its 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 |
---|---|---|---|
Fertility Center of Orlando | Biologics | 11/21/2023 | Voluntary Action Indicated (VAI) |
OneBlood, Inc. | Biologics | 10/16/2023 | No Action Indicated (NAI) |
Pathen Medical, LLC | Devices | 12/13/2023 | No Action Indicated (NAI) |