During an inspection on December 17, 2024, the Food and Drug Administration (FDA) issued two citations to Jackson Memorial Hospital Transfusion Medicine Services in Miami related to their handling of blood and blood products, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘Equipment used in the compatibility testing and storage and distribution of blood and blood components is not observed and standardized on a regularly scheduled basis as prescribed in the SOP Manual.’
- ‘Records are not concurrently maintained with the performance of each significant step in the storage of each unit of blood and blood components so that all steps can be clearly traced.’
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.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
