Norfolk Reporter

There was one company in a city associated with Norfolk 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 were 'Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed' and 'The accuracy, sensitivity, specificity and reproducibility of test methods have not been 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Fresenius Kabi Compounding, LLC	Drugs	03/06/2023	Procedures for sterile drug products
Fresenius Kabi Compounding, LLC	Drugs	03/06/2023	Test methods