SE Twin Cities

There were two companies in cities associated with Le Sueur County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

• An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• You offered a food-producing animal(s) for interstate commerce that was found to bear or contain a drug residue in an edible tissue above an established safe level, safe concentration, or tolerance.
• You did not maintain complete treatment records.

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.

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
Electromed, Inc.	Devices	01/13/2023	Individual Report of Malfunction
Saemrow Dairy	Veterinary	07/12/2023	Introduction/delivery into IS - illegal drug residue
Saemrow Dairy	Veterinary	07/12/2023	Record keeping