Dubuque Times

There was one company in a city associated with Dubuque 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 unchanged from the number of companies cited in the previous year.

The citations in the county include:

• Routine calibration and inspection of mechanical equipment is not performed according to a written program designed to assure proper performance.
• Representative samples are not taken of each shipment of each lot of components, drug product containers and closures for testing or examination.
• Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

The company cited had to take regulatory and/or administrative actions.

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
Higley Industries, Inc.	Drugs	09/21/2023	Calibration/Inspection/Checking not done
Higley Industries, Inc.	Drugs	09/21/2023	Representative Samples
Higley Industries, Inc.	Drugs	09/21/2023	Control procedures to monitor and validate performance
Higley Industries, Inc.	Drugs	09/21/2023	Scientifically sound laboratory controls
Higley Industries, Inc.	Drugs	09/21/2023	Complete instructions, procedures, specifications et. al.
Higley Industries, Inc.	Drugs	09/21/2023	Quality control unit review of records