SC Nebraska News

There were two companies in a city associated with Dawson County that received FDA citations as a result of two inspections conducted in the county throughout 2023, 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 year.

The citations in the county include:

• You did not identify and implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.
• Representative samples are not taken of each shipment of each lot of drug product containers and closures for testing or examination.
• Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Both companies cited should take voluntary actions to correct their 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
Chief Ethanol Fuels, Inc.	Veterinary	06/14/2023	Preventive Controls
EPM Packaging, Inc.	Drugs	01/12/2023	Representative Samples
EPM Packaging, Inc.	Drugs	01/12/2023	Absence of Written Procedures
EPM Packaging, Inc.	Drugs	01/12/2023	In-Process and Laboratory Control Results