Buffalo Ledger

There were two companies in cities associated with Erie County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• You did not validate that your process controls are adequate to control the hazard.
• A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
• 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.

Both companies cited should take voluntary actions to correct their 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.
Fruit Fresh Up, Inc.	Food and Cosmetics	03/21/2024	Process controls - Validation