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 an increase over the number of companies cited in the previous quarter.
The citations in the county were 'A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures' and 'Procedures for acceptance activities have not been established'.
The company cited should take a voluntary action to correct its managing 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.
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 | Issue Cited |
|---|---|---|---|
| dBMEDx, Inc. | Devices | 03/27/2025 | Lack of or inadequate process validation |
| dBMEDx, Inc. | Devices | 03/27/2025 | Lack of or inadequate procedures - Acceptance activities |
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