Omaha City Wire

There were three companies in a city associated with Douglas County that received FDA citations as a result of three inspections 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:

• You did not employ at least one supervisor or responsible party that has successfully completed appropriate food safety training.
• You did not maintain food contact surfaces as frequently as necessary to protect against the contamination of produce.
• You did not test spent irrigation water from each production batch of sprouts for E. coli O157:H7 and Salmonella.

All of the companies cited were involved in either Food and Cosmetics, Devices, or Veterinary sectors.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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
ABS Corporation	Veterinary	08/11/2023	Procedures not in writing, fully followed
ABS Corporation	Veterinary	08/11/2023	Computer control of master formula records
ABS Corporation	Veterinary	08/11/2023	Absence of Written Procedures
ABS Corporation	Veterinary	08/11/2023	No written record of investigation
Innovative Medical Technologies, Inc.	Devices	09/28/2023	Design validation- Lack of or inadequate procedures
Innovative Medical Technologies, Inc.	Devices	09/28/2023	Design history file
Sun Sprouts, LLC	Food and Cosmetics	01/06/2023	Training for supervisors
Sun Sprouts, LLC	Food and Cosmetics	01/06/2023	Food contact surface sanitary inspection and maintenance
Sun Sprouts, LLC	Food and Cosmetics	01/06/2023	Testing spent irrigation water
Sun Sprouts, LLC	Food and Cosmetics	01/06/2023	Release before negative test results
Sun Sprouts, LLC	Food and Cosmetics	01/06/2023	Method - irrigation water - sprouts
Sun Sprouts, LLC	Food and Cosmetics	01/06/2023	Record requirements