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Kane County Reporter

Thursday, November 21, 2024

FDA: 1 company in cities within Kendall County received 3 citations in 2023

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

There was one company in a city associated with Kendall County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 66.7% decrease from the number of companies cited in the previous year.

The citations in the county include:

  • Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
  • Procedures for quality audits have not been adequately established.
  • Procedures for corrective and preventive action have not been adequately established.

The company cited should take a voluntary action to correct its 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.

Companies Located Within Kendall County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Stericycle, Inc.Devices12/21/2023Management review - defined interval, sufficient frequency
Stericycle, Inc.Devices12/21/2023Quality audits - Lack of or inadequate procedures
Stericycle, Inc.Devices12/21/2023Lack of or inadequate procedures

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