There were two companies in a city associated with Knox County that received FDA citations as a result of two inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not take a reasonable measure or precaution related to personnel practices.
- Your plant was not constructed and designed to facilitate maintenance and sanitary operations.
- Donor screening of HCT/P donors considered eligible indicated that the donor was not free of risk factors for infection due to communicable disease agents.
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.
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 |
|---|---|---|---|
| Fertility Center, LLC | Biologics | 09/18/2024 | Donor screening standards |
| Fertility Center, LLC | Biologics | 09/18/2024 | Eligibility not required–warning labels |
| The Copper Cellar Corporation | Food and Cosmetics | 02/14/2024 | Personnel |
| The Copper Cellar Corporation | Food and Cosmetics | 02/14/2024 | Plant construction and design |
