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Sunday, December 22, 2024

FDA issued 12 citations in cities across Dane County in Q4 2023

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

There were four companies in cities associated with Dane County that received FDA citations as a result of four 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 300% increase over the number of companies cited in the previous quarter.

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.

Of the companies cited, four should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (25%).

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 Dane County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Compass Group USA, Inc.Food and Cosmetics11/27/2023Modified requirement: Temperature control - Implement
Dairyfood USA, Inc.Food and Cosmetics12/28/2023Range, chart graduations
Dairyfood USA, Inc.Food and Cosmetics12/28/2023Critical factors not stated
Dairyfood USA, Inc.Food and Cosmetics12/28/2023Evaluation records
Dairyfood USA, Inc.Food and Cosmetics12/28/2023Process deviation log/file
Porchlight, Inc.Food and Cosmetics12/01/2023Process adherence
Porchlight, Inc.Food and Cosmetics12/01/2023Quality control procedures
Porchlight, Inc.Food and Cosmetics12/01/2023Maintenance of processing and production records
Porchlight, Inc.Food and Cosmetics12/01/2023Personnel
Porchlight, Inc.Food and Cosmetics12/01/2023Sanitary operations - Plant sanitation
Wagner Dairy Operations, LLCVeterinary12/08/2023Introduction/delivery into IS - illegal drug residue
Wagner Dairy Operations, LLCVeterinary12/08/2023Record keeping

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