Southside VA News

There was one company in a city associated with Henry 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:

• Software used as part of production has not been adequately validated for its intended use according to an established protocol.
• Procedures for acceptance activities have not been adequately established.
• Procedures have not been adequately established to control product that does not conform to specified requirements.

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
Sleepsafe Beds, LLC	Devices	10/19/2023	Software validation for automated processes
Sleepsafe Beds, LLC	Devices	10/19/2023	Lack of or inadequate procedures - Acceptance activities
Sleepsafe Beds, LLC	Devices	10/19/2023	Nonconforming product, Lack of or inadequate procedures
Sleepsafe Beds, LLC	Devices	10/19/2023	Lack of or inadequate procedures