Buffalo Ledger

There was one company in a city associated with Erie County that received FDA citations as a result of one inspection conducted in the county in February, 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 month.

The citations in the county were 'A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures' and 'The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided'.

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
Avox Systems, Inc.	Devices	02/02/2024	Lack of or inadequate process validation
Avox Systems, Inc.	Devices	02/02/2024	Devices subject to device identification GUDID data submission requirements.