Buffalo Ledger

There were three companies in cities associated with Erie County that received FDA citations as a result of three inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% increase over the number of companies cited in the previous quarter.

Of the 16 citations issued, the most common citations include:

• The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
• Personnel training is not documented.
• Procedures for corrective and preventive action have not been adequately established.

Most of the companies cited were involved in the Devices sector.

All of the 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
Fresenius Kabi USA, LLC	Drugs	10/13/2023	Procedures for sterile drug products
Fresenius Kabi USA, LLC	Drugs	10/13/2023	Investigations of discrepancies, failures
Orthodent Laboratory, Inc.	Devices	11/13/2023	Label to bear a unique device identifier
Orthodent Laboratory, Inc.	Devices	11/13/2023	Training records
Orthodent Laboratory, Inc.	Devices	11/13/2023	Purchasing controls, Lack of or inadequate procedures
Orthodent Laboratory, Inc.	Devices	11/13/2023	Process control procedures, Lack of or inadequate procedures
Orthodent Laboratory, Inc.	Devices	11/13/2023	Software validation for automated processes
Orthodent Laboratory, Inc.	Devices	11/13/2023	Incoming acceptance records, documentation
Orthodent Laboratory, Inc.	Devices	11/13/2023	Lack of or inadequate procedures
Orthodent Laboratory, Inc.	Devices	11/13/2023	DHR content
Orthodent Laboratory, Inc.	Devices	11/13/2023	Devices subject to device identification GUDID data submission requirements.
You First Services, Inc.	Devices	12/18/2023	Label to bear a unique device identifier
You First Services, Inc.	Devices	12/18/2023	Training records
You First Services, Inc.	Devices	12/18/2023	Lack of or inadequate procedures
You First Services, Inc.	Devices	12/18/2023	Lack of or inadequate complaint procedures
You First Services, Inc.	Devices	12/18/2023	Devices subject to device identification GUDID data submission requirements.