Eagle Valley Times

There was one company in Carson City that received FDA citations as a result of one inspection conducted in the city over the first 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 city include:

• Risk analysis is incomplete.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
• Production processes were not developed to ensure that a device conforms to its specifications.

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
Dsaart, LLC	Devices	03/01/2024	Design Validation - Risk analysis not performed/inadequate
Dsaart, LLC	Devices	03/01/2024	Purchasing controls, Lack of or inadequate procedures
Dsaart, LLC	Devices	03/01/2024	Production processes
Dsaart, LLC	Devices	03/01/2024	Lack of or inadequate process validation