Ann Arbor Times

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

This is unchanged from the number of companies cited in the previous quarter.

Of the 10 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

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

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
Axiobionics, LLC	Devices	11/22/2024	Management review - defined interval, sufficient frequency
Axiobionics, LLC	Devices	11/22/2024	Lack of or inadequate procedures
Axiobionics, LLC	Devices	11/22/2024	Investigation of device failures
Danmar Products, Inc.	Devices	11/04/2024	Training records
Danmar Products, Inc.	Devices	11/04/2024	Documented evaluation
Danmar Products, Inc.	Devices	11/04/2024	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Danmar Products, Inc.	Devices	11/04/2024	Documentation
Danmar Products, Inc.	Devices	11/04/2024	Lack of or inadequate receiving acceptance procedures
Danmar Products, Inc.	Devices	11/04/2024	Lack of or inadequate procedures
Danmar Products, Inc.	Devices	11/04/2024	Lack of or inadequate complaint procedures