How many companies in cities across Genesee County received FDA citations in 2023?

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

By Genesee News

Oct 28, 2024

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

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

Written MDR procedures have not been developed, maintained and implemented.
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
Procedures for acceptance of incoming product have not been established.

The companies cited were involved in either Devices or Veterinary sectors.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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.

Companies Located Within Genesee County Cities and the Citations They Received in 2023

Company Name	Area of Business	Inspection Date	Issue Cited
Best Buy Bones, Inc.	Veterinary	02/13/2023	Personnel
Best Buy Bones, Inc.	Veterinary	02/13/2023	Manufacturing, Processing, Packing, Holding - Measures
Best Buy Bones, Inc.	Veterinary	02/13/2023	Hazard Analysis
Best Buy Bones, Inc.	Veterinary	02/13/2023	Preventive Controls
Best Buy Bones, Inc.	Veterinary	02/13/2023	Environmental Monitoring
Best Buy Bones, Inc.	Veterinary	02/13/2023	Supply-Chain Program Establish and Implement
CXMedUS, Inc.	Devices	04/06/2023	Lack of Written MDR Procedures
CXMedUS, Inc.	Devices	04/06/2023	Purchasing controls, Lack of or inadequate procedures
CXMedUS, Inc.	Devices	04/06/2023	Lack of or inadequate receiving acceptance procedures
CXMedUS, Inc.	Devices	04/06/2023	Lack of or inadequate procedures
CXMedUS, Inc.	Devices	04/06/2023	Lack of or inadequate complaint procedures