South Hennepin News

There were three companies in a city associated with Hennepin County that received FDA citations as a result of three inspections conducted in the county over the fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
• Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
• Procedures for corrective and preventive action have not been adequately established.

Most of the companies cited were involved in the Devices sector.

All of the 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
Hangtime	Food and Cosmetics	12/13/2024	Process deviation evaluation - record
Hangtime	Food and Cosmetics	12/13/2024	Raw materials, packaging, finished product
Hangtime	Food and Cosmetics	12/13/2024	Maintenance of processing and production records
Hangtime	Food and Cosmetics	12/13/2024	Equipment and utensils - Design and maintenance
NeuroOne Medical Technologies Corporation	Devices	10/28/2024	Design Validation - Risk analysis not performed/inadequate
NeuroOne Medical Technologies Corporation	Devices	10/28/2024	Design validation- Lack of or inadequate procedures
Pathy Medical, LLC	Devices	11/19/2024	Management review - defined interval, sufficient frequency
Pathy Medical, LLC	Devices	11/19/2024	Lack/Inad procedure-Monitoring/Control of Validated Proces
Pathy Medical, LLC	Devices	11/19/2024	Lack of or inadequate procedures