Lake County Gazette

There were five companies in cities associated with Lake County that received FDA citations as a result of six inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 25% increase over the number of companies cited in the previous quarter.

Of the 10 citations issued, the most common citation was 'You did not develop an FSVP'.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, four should take voluntary actions to correct their managing operations (80%). Additionally, one company had to take regulatory and/or administrative actions (20%).

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
Ans Seafood, Inc.	Food and Cosmetics	12/14/2023	Develop FSVP
Ans Seafood, Inc.	Food and Cosmetics	12/14/2023	Importer verification
Bende, Inc.	Food and Cosmetics	12/22/2023	Hazard analysis biological, chemical, physical
Bende, Inc.	Food and Cosmetics	12/22/2023	Verification activity - appropriate
Cardinal Health 200, LLC	Devices	12/20/2023	Purchasing controls, Lack of or inadequate procedures
Cardinal Health 200, LLC	Devices	12/20/2023	Lack of or inadequate procedures
Cardinal Health 200, LLC	Devices	12/20/2023	Sampling plans
Cheshni Foods, LLC	Food and Cosmetics	11/17/2023	Develop FSVP
Cheshni Foods, LLC	Food and Cosmetics	11/17/2023	Very small importer assurances, supplier
FiMex, Inc.	Food and Cosmetics	10/20/2023	Develop FSVP