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 throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• There is no documentation of the revalidation of a process performed in response to changes or process deviations.
• Procedures for rework of nonconforming product have not been established.
• Procedures for corrective and preventive action have not been adequately established.

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
Frantz Medical Development, Ltd.	Devices	06/27/2023	Documentation - review in response to changes or deviations
Frantz Medical Development, Ltd.	Devices	06/27/2023	Product rework procedures, Lack of or inadequate procedures
Frantz Medical Development, Ltd.	Devices	06/27/2023	Lack of or inadequate procedures
Frantz Medical Development, Ltd.	Devices	06/27/2023	Documentation
Frantz Medical Development, Ltd.	Devices	06/27/2023	Statistical techniques - Lack of or inadequate procedures