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Wednesday, September 17, 2025

How many companies in cities across Hennepin County received FDA citations in August?

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James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

There were two companies in cities associated with Hennepin County that received FDA citations as a result of two inspections conducted in the county in August, 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 month.

Of the six citations issued, the most common citations were 'Procedures for finished device acceptance have not been adequately established' and 'Procedures for corrective and preventive action have not been adequately established'.

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 and quality.

Companies located within Hennepin County Cities and the citations they received in August
Company NameArea of BusinessInspection DateIssue Cited
Simple Science, LLCDevices08/07/2025Evaluation of suppliers, contractors, etc., requirements
Simple Science, LLCDevices08/07/2025Lack of or inadequate final acceptance procedures
Simple Science, LLCDevices08/07/2025Nonconforming product, Lack of or inadequate procedures
Simple Science, LLCDevices08/07/2025Lack of or inadequate procedures
Steris LaboratoriesDevices08/01/2025Lack of or inadequate final acceptance procedures
Steris LaboratoriesDevices08/01/2025Lack of or inadequate procedures

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