Syracuse Sun

There was one company in a city associated with Onondaga 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 an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
• A device master record has not been maintained.
• The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).

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
Glottal Enterprises, Inc.	Devices	10/17/2024	Purchasing controls, Lack of or inadequate procedures
Glottal Enterprises, Inc.	Devices	10/17/2024	DMR - not or inadequately maintained
Glottal Enterprises, Inc.	Devices	10/17/2024	DHR - UDI not included
Glottal Enterprises, Inc.	Devices	10/17/2024	GUDID Designation of contact for device identification.