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 unchanged from the number of companies cited in the previous year.
The citations in the county were 'A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures' and 'Your quality control personnel did not review and approve decisions about whether to investigate a product complaint'.
Both companies cited should take voluntary actions to correct their 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.
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 | Issue Cited |
|---|---|---|---|
| Core Nutritionals, LLC | Food and Cosmetics | 03/23/2023 | Quality control, review, approve; investigate, follow-up |
| Structure Medical, LLC | Devices | 05/05/2023 | Lack of or inadequate process validation |
Alerts Sign-up