Lake County Times

There was one company in a city associated with Lake County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2024, 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 quarter.

The citations in the county include:

• Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
• Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
• Procedures have not been adequately established to control product that does not conform to specified requirements.

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
LS Investment Group II, LLC	Devices	10/30/2024	Process control procedures, Lack of or inadequate procedures
LS Investment Group II, LLC	Devices	10/30/2024	Lack/Inad procedure-Monitoring/Control of Validated Proces
LS Investment Group II, LLC	Devices	10/30/2024	Nonconforming product, Lack of or inadequate procedures
LS Investment Group II, LLC	Devices	10/30/2024	Lack of or inadequate procedures