SC Minnesota News

There was one company in a city associated with Waseca County that received FDA citations 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 an increase over the number of companies cited in the previous year.

The citations in the county include:

• The personnel you identified to perform quality control operations do not have distinct and separate responsibilities related to performing such operations from those responsibilities that the personnel otherwise have when not performing such operations.
• You did not establish a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
• Your batch production record did not include complete information relating to the production and control of each batch.

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
Midwest Extraction Services, LLC	Food and Cosmetics	01/30/2023	Personnel - quality control operations; responsibilities
Midwest Extraction Services, LLC	Food and Cosmetics	01/30/2023	Specifications - manufacturing process
Midwest Extraction Services, LLC	Food and Cosmetics	01/30/2023	Batch record - complete
Midwest Extraction Services, LLC	Food and Cosmetics	01/30/2023	Conditions, controls -protect; microorganisms, contamination
Midwest Extraction Services, LLC	Food and Cosmetics	01/30/2023	Quality control - processes, specifications, written procedures