Cincy Reporter

There was one company in a city associated with Hamilton 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 83.3% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Procedures have not been adequately established to control product that does not conform to specified requirements.
• Procedures for corrective and preventive action have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit 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
Surgical Appliance Industries, Inc.	Devices	10/18/2023	Nonconforming product, Lack of or inadequate procedures
Surgical Appliance Industries, Inc.	Devices	10/18/2023	Lack of or inadequate procedures
Surgical Appliance Industries, Inc.	Devices	10/18/2023	Lack of or inadequate complaint procedures