Austin News

There was one company in a city associated with Travis County that received FDA citations as a result of one inspection conducted in the county in July, 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 month.

The citations in the county were 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established' and 'Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by a designated individual and clearly identified'.

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
NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION, LLC	Devices	07/03/2024	Lack of or inadequate complaint procedures
NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION, LLC	Devices	07/03/2024	Evaluation, timeliness, identification