Lake County Gazette

There were 11 companies in cities associated with Lake County that received FDA citations as a result of 15 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 38.9% decrease from the number of companies cited in the previous year.

Of the 27 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. The second most common type of company cited in the time period worked in the the Devices sector.

Of the companies cited, 10 should take voluntary actions to correct their managing operations (90.9%). Additionally, two companies had to take regulatory and/or administrative actions (18.2%).

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
Aherb USA, Inc.	Food and Cosmetics	03/31/2023	Supplier approval - document
Ans Seafood, Inc.	Food and Cosmetics	12/14/2023	Develop FSVP
Ans Seafood, Inc.	Food and Cosmetics	12/14/2023	Importer verification
Baxter Healthcare Corporation	Devices	08/18/2023	Design validation- Lack of or inadequate procedures
Bende, Inc.	Food and Cosmetics	12/22/2023	Hazard analysis biological, chemical, physical
Bende, Inc.	Food and Cosmetics	12/22/2023	Verification activity - appropriate
Bende, Inc.	Food and Cosmetics	03/29/2023	Develop FSVP
Blackwing Organic Meats, Inc.	Food and Cosmetics	07/13/2023	Sanitary operations - Plant sanitation
Blackwing Organic Meats, Inc.	Food and Cosmetics	07/13/2023	Record availability
Bozic'S Imports & Wholesale Liquors	Food and Cosmetics	07/19/2023	Develop FSVP
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	04/28/2023	Develop FSVP
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
FiMex, Inc.	Food and Cosmetics	05/12/2023	Hazard analysis biological, chemical, physical
FiMex, Inc.	Food and Cosmetics	05/12/2023	Evaluation - performance, risk
FiMex, Inc.	Food and Cosmetics	05/12/2023	Supplier approval - document
FiMex, Inc.	Food and Cosmetics	05/12/2023	Approved supplier procedures - importer established
FiMex, Inc.	Food and Cosmetics	05/12/2023	Supplier verification - establish written procedures
Giannetti Artisans, Inc.	Food and Cosmetics	09/28/2023	Supplier verification - establish written procedures
Giannetti Artisans, Inc.	Food and Cosmetics	09/28/2023	Verification activity frequency
Giannetti Artisans, Inc.	Food and Cosmetics	09/28/2023	Verification activity - appropriate
SGS North America, Inc.	Drugs	01/10/2023	Investigations of discrepancies, failures
SGS North America, Inc.	Veterinary	01/10/2023	Investigations of discrepancies, failures