Hutch Today

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

This is an increase over the number of companies cited in the previous month.

The citations in the county include:

• 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.
• Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
• There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

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.

According to its website, 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Hospira, A Pfizer Company, Inc.	Drugs	01/17/2025	Control procedures to monitor and validate performance
Hospira, A Pfizer Company, Inc.	Drugs	01/17/2025	Procedures for sterile drug products
Hospira, A Pfizer Company, Inc.	Drugs	01/17/2025	Investigations of discrepancies, failures