Hartford Reporter

There were two companies in cities associated with Hartford County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous year.

Of the 10 citations issued, the most common citation was 'You did not implement your sanitation verification procedures'.

The companies cited were involved in either Devices or Food and Cosmetics sectors.

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
Kal-Med, LLC	Devices	03/31/2023	Design changes - Lack of or Inadequate Procedures
Kal-Med, LLC	Devices	03/31/2023	Purchasing controls, Lack of or inadequate procedures
Kal-Med, LLC	Devices	03/31/2023	DHR - UDI not included
The Royal Ice Cream Company, Inc.	Food and Cosmetics	01/25/2023	Hazard analysis - Identification of hazard
The Royal Ice Cream Company, Inc.	Food and Cosmetics	01/25/2023	Allergen preventive controls - Implement
The Royal Ice Cream Company, Inc.	Food and Cosmetics	01/25/2023	Sanitation preventive controls - Implement
The Royal Ice Cream Company, Inc.	Food and Cosmetics	01/25/2023	Process preventive controls - Appropriate (Adequate)
The Royal Ice Cream Company, Inc.	Food and Cosmetics	01/25/2023	Allergen preventive controls - Appropriate (Adequate)
The Royal Ice Cream Company, Inc.	Food and Cosmetics	01/25/2023	Sanitation preventive controls - Appropriate (Adequate)
The Royal Ice Cream Company, Inc.	Food and Cosmetics	10/10/2023	Sanitation preventive controls - Implement