Nassau Standard

There was one company in a city associated with Nassau County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

• Procedures for design change have not been adequately established.
• There is no agreement with contractors to notify you of changes in the product or service.
• 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
Advanced Back Technologies, Inc.	Devices	10/31/2024	Design changes - Lack of or Inadequate Procedures
Advanced Back Technologies, Inc.	Devices	10/31/2024	Supplier notification of changes
Advanced Back Technologies, Inc.	Devices	10/31/2024	Lack of or inadequate procedures
Advanced Back Technologies, Inc.	Devices	10/31/2024	DHR - not or inadequately maintained