North Baltimore Journal

There were two companies in the City of Baltimore that received FDA citations as a result of two inspections conducted in the city over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous quarter.

The citations in the city include:

• Written standard operating procedures including all steps to be followed in the compatibility testing and distribution of blood and blood components for allogeneic transfusion were not always maintained.
• Records including signature by the physician requesting the procedure are not maintained of all emergency transfusions.
• You did not take a reasonable measure or precaution related to personnel practices.

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
Baltimore Baked Goods, LLC	Food and Cosmetics	03/20/2025	Personnel
Baltimore Baked Goods, LLC	Food and Cosmetics	03/20/2025	Sanitation of food-contact surfaces - Frequency
Johns Hopkins Hospital Blood Bank	Biologics	02/13/2025	Establish, maintain and follow manufacturing SOPs
Johns Hopkins Hospital Blood Bank	Biologics	02/13/2025	Procedures to maintain records of emergency transfusions