Indy Standard

There were four companies in a city associated with Marion County that received FDA citations as a result of four inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous quarter.

Of the nine citations issued, the most common citation was 'Your written sanitation preventive control, monitoring and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control'.

Most of the companies cited were involved in the Food and Cosmetics sector.

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.

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
Krispy Kreme Doughnut Corporation	Food and Cosmetics	03/07/2024	Sanitation preventive controls - Implement
Krispy Kreme Doughnut Corporation	Food and Cosmetics	03/07/2024	Sanitation preventive controls - Appropriate (Adequate)
Mondelez Global, LLC	Food and Cosmetics	01/11/2024	Sanitation preventive controls - Appropriate (Adequate)
Vesta Pharmaceuticals, Inc.	Food and Cosmetics	02/09/2024	Quality control operations - calibration records
Vesta Pharmaceuticals, Inc.	Food and Cosmetics	02/09/2024	Batch record - quality control review; production
Vesta Pharmaceuticals, Inc.	Food and Cosmetics	02/09/2024	Hold - mix-up, contamination, deterioration