Mohave Today

There was one company in a city associated with Mohave 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:

• Procedures for quality audits have not been adequately established.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
• A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.

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
Oto Med, Inc.	Devices	08/30/2024	Quality audits - Lack of or inadequate procedures
Oto Med, Inc.	Devices	08/30/2024	Purchasing controls, Lack of or inadequate procedures
Oto Med, Inc.	Devices	08/30/2024	Lack of or inadequate process validation
Oto Med, Inc.	Devices	08/30/2024	Documentation
Oto Med, Inc.	Devices	08/30/2024	Lack of or inadequate DHR procedures
Oto Med, Inc.	Devices	08/30/2024	Complaints