Green Bay Reporter

There was one company in a city associated with Brown County that received FDA citations as a result of one inspection conducted in the county over the third quarter of 2024, 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 quarter.

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.
• Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.
• Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.

The company cited was involved in the Devices sector.

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
Little Rapids Corporation	Devices	08/23/2024	Individual Report of Malfunction
Little Rapids Corporation	Devices	08/23/2024	Management ensuring quality policy is understood
Little Rapids Corporation	Devices	08/23/2024	Quality Audits - defined intervals
Little Rapids Corporation	Devices	08/23/2024	Training records
Little Rapids Corporation	Devices	08/23/2024	Purchasing controls, Lack of or inadequate procedures
Little Rapids Corporation	Devices	08/23/2024	Lack of or inadequate receiving acceptance procedures
Little Rapids Corporation	Devices	08/23/2024	Nonconforming product, Lack of or inadequate procedures
Little Rapids Corporation	Devices	08/23/2024	Documentation
Little Rapids Corporation	Devices	08/23/2024	Lack of or inadequate complaint procedures