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 over the fourth quarter of 2023, 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.

The citations in the county include:

• Procedures were not designed to ensure compliance with the donor eligibility requirements.
• Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
• Donors were not tested for evidence of infection with relevant communicable disease agents.

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
Endangered Species Chocolate, LLC	Food and Cosmetics	10/18/2023	Pest control
Endangered Species Chocolate, LLC	Food and Cosmetics	10/18/2023	Allergen preventive controls - Identify (Written)
Family Beginnings, PC	Biologics	11/20/2023	Design of procedures to ensure compliance
Family Beginnings, PC	Biologics	11/20/2023	Risk factors, clinical evidence
Family Beginnings, PC	Biologics	11/20/2023	Infection with communicable disease agents