Indy Standard

There were two companies in a city associated with Marion County that received FDA citations as a result of two inspections conducted in the county in January, 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 month.

The citations in the county include:

• Your written sanitation preventive control, monitoring and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control.
• Procedures were not designed to ensure compliance with the donor eligibility requirements.
• Documentation of the donor-eligibility determination was not maintained.

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
Community Fertility Specialty Care	Biologics	01/11/2024	Design of procedures to ensure compliance
Community Fertility Specialty Care	Biologics	01/11/2024	Documentation--determination, by whom, date
Community Fertility Specialty Care	Biologics	01/11/2024	Infection with communicable disease agents
Mondelez Global, LLC	Food and Cosmetics	01/11/2024	Sanitation preventive controls - Appropriate (Adequate)