North Indy News

There were three companies in cities associated with Hamilton County that received FDA citations as a result of three inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 200% increase over the number of companies cited in the previous year.

The citations in the county include:

• You did not discontinue the use of all from a lot for which you know or have reason to believe that the were contaminated with a pathogen.
• You did not test for Listeria spp. or Listeria monocytogenes in your growing, harvesting, packing and holding environment.
• You did not establish and maintain procedures for screening of HCT/P donors.

All of the 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.

According to its website, 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.

Company Name	Area of Business	Inspection Date	Issue Cited
China Farms, Inc.	Food and Cosmetics	09/19/2024	Discontinue using seed
China Farms, Inc.	Food and Cosmetics	09/19/2024	Environmental testing requirements
Infrared Laboratories, LLC	Devices	04/01/2024	Design output - Lack of or inadequate procedures
Midwest Fertility Specialists	Biologics	11/25/2024	Testing, screening, donor eligibility procedures
Midwest Fertility Specialists	Biologics	11/25/2024	Risk factors, clinical evidence