The Region News

There were two companies in cities associated with Porter County that received FDA citations as a result of two inspections conducted in the county throughout 2023, 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 year.

The citations in the county include:

• Procedures have not been adequately established to control product that does not conform to specified requirements.
• You did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
• The accompanying records for HCT/Ps included the donor's name and personal information that might identify the donor.

Both companies cited should take voluntary actions to correct their 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
Advanced Reproductive Health Center, Chicago IVF, Ltd.	Biologics	07/05/2023	Testing, screening, donor eligibility procedures
Advanced Reproductive Health Center, Chicago IVF, Ltd.	Biologics	07/05/2023	Name and personal info on accompanying records
Advanced Reproductive Health Center, Chicago IVF, Ltd.	Biologics	07/05/2023	Abbreviated procedure
Davryan Laboratories, Inc.	Devices	10/11/2023	Nonconforming product, Lack of or inadequate procedures