There was one company in a city associated with Hopkins County that received FDA citations as a result of one inspection conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
No companies were cited in the previous year.
The citations in the county were ‘Written standard operating procedures including all steps to be followed in the collection and processing of blood and blood components for allogeneic transfusion and further manufacturing purposes were not always established and followed’ and ‘Failure to perform a thorough investigation of an unexplained discrepancy’.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Baptist Health Deaconess Madisonville, Inc. | Biologics | 04/24/2025 | Establish, maintain and follow manufacturing SOPs |
| Baptist Health Deaconess Madisonville, Inc. | Biologics | 04/24/2025 | Thorough investigations |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
