North Jefferson County News

There were two companies in cities associated with Adams County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2024, 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 quarter.

The citations in the county include:

• Procedures for design change have not been adequately established.
• Procedures for acceptance activities have not been adequately established.
• Procedures for corrective and preventive action have not been adequately established.

Both companies cited were involved in the Devices sector.

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
Newman Medical	Devices	09/25/2024	Design changes - Lack of or Inadequate Procedures
Newman Medical	Devices	09/25/2024	Lack of or inadequate procedures - Acceptance activities
Newman Medical	Devices	09/25/2024	Lack of or inadequate procedures
Newman Medical	Devices	09/25/2024	DMR - not or inadequately maintained
Newman Medical	Devices	09/25/2024	DHR - not or inadequately maintained
Newman Medical	Devices	09/25/2024	Servicing - Lack of or inadequate procedures
WalkMed, LLC	Devices	09/13/2024	Lack of System for Event Evaluations
WalkMed, LLC	Devices	09/13/2024	Individual Report of Malfunction
WalkMed, LLC	Devices	09/13/2024	Design Validation - Risk analysis not performed/inadequate
WalkMed, LLC	Devices	09/13/2024	Lack of or inadequate complaint procedures