Madison Reporter

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

This is an 11.1% decrease from the number of companies cited in the previous year.

The citations in the county include:

• Graduations on a temperature-recording device chart exceeded 2 °F (1°C) within a range of 10 °F (5 °C) of the process temperature.
• A critical factor that may affect the scheduled process was not specified in the scheduled process.
• No records were made of the procedures and results of the evaluation done by a process authority following a deviation from the scheduled process.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

Of the companies cited, eight should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (12.5%).

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
Compass Group USA, Inc.	Food and Cosmetics	11/27/2023	Modified requirement: Temperature control - Implement
Dairyfood USA, Inc.	Food and Cosmetics	12/28/2023	Range, chart graduations
Dairyfood USA, Inc.	Food and Cosmetics	12/28/2023	Critical factors not stated
Dairyfood USA, Inc.	Food and Cosmetics	12/28/2023	Evaluation records
Dairyfood USA, Inc.	Food and Cosmetics	12/28/2023	Process deviation log/file
Datex-Ohmeda, Inc.	Devices	11/17/2023	Lack of or inadequate procedures
Elegant Foods, LLC	Food and Cosmetics	07/28/2023	Hazard analysis - Identification of hazard
Merit CRO, Inc.	Devices	04/28/2023	Nonconforming product, Lack of or inadequate procedures
Porchlight, Inc.	Food and Cosmetics	12/01/2023	Process adherence
Porchlight, Inc.	Food and Cosmetics	12/01/2023	Quality control procedures
Porchlight, Inc.	Food and Cosmetics	12/01/2023	Maintenance of processing and production records
Porchlight, Inc.	Food and Cosmetics	12/01/2023	Personnel
Porchlight, Inc.	Food and Cosmetics	12/01/2023	Sanitary operations - Plant sanitation
Quincy Bioscience Holding Company, Inc.	Food and Cosmetics	03/16/2023	Animals and pests in facility
Wagner Dairy Operations, LLC	Veterinary	12/08/2023	Introduction/delivery into IS - illegal drug residue
Wagner Dairy Operations, LLC	Veterinary	12/08/2023	Record keeping