WC Wisconsin News

There was one company in a city associated with La Crosse County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 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 quarter.

The citations in the county include:

• The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
• Risk analysis was not performed.
• Procedures for corrective and preventive action have not been adequately established.

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
Aquila Corporation	Devices	12/07/2023	Label to bear a unique device identifier
Aquila Corporation	Devices	12/07/2023	Design Validation - Risk analysis not performed/inadequate
Aquila Corporation	Devices	12/07/2023	Lack of or inadequate procedures
Aquila Corporation	Devices	12/07/2023	Lack of or inadequate complaint procedures