SC Minnesota News

There was one company in a city associated with Blue Earth County that received FDA citations as a result of one inspection conducted in the county in April, 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 month.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
• Drug products are not stored under appropriate conditions of temperature, humidity and light so that their identity, strength, quality, and purity are not affected.

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
Coloplast Manufacturing US, LLC	Drugs	04/11/2024	Procedures not in writing, fully followed
Coloplast Manufacturing US, LLC	Drugs	04/11/2024	Procedures for non-sterile drug products
Coloplast Manufacturing US, LLC	Drugs	04/11/2024	Storage under appropriate conditions