The Region News

There was one company in a city associated with Lake County that received an FDA citation as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous year.

The only citation issued in the county was delivered as 'Written standard operating procedures including all steps to be followed in the storage of blood and blood components for were not always'.

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.

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
The American National Red Cross	Biologics	06/27/2023	Establish, maintain and follow manufacturing SOPs