East Sierra News

There was one company in a city associated with Inyo County that received FDA citations as a result of one inspection conducted in the county throughout 2023, 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 year.

The citations in the county include:

• The design history file was not established.
• Document control procedures have not been adequately established and maintained.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.

The company cited had to take regulatory and/or administrative actions.

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
NeuroField, Inc.	Devices	06/23/2023	Design history file
NeuroField, Inc.	Devices	06/23/2023	Procedures not adequately established or maintained
NeuroField, Inc.	Devices	06/23/2023	Purchasing controls, Lack of or inadequate procedures
NeuroField, Inc.	Devices	06/23/2023	Software validation for automated processes
NeuroField, Inc.	Devices	06/23/2023	Nonconforming product, Lack of or inadequate procedures
NeuroField, Inc.	Devices	06/23/2023	Lack of or inadequate procedures