FDA issued 9 citations in cities across DeKalb County in Q1

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

By ATL Standard

Apr 21, 2024

There were two companies in cities associated with DeKalb County that received FDA citations as a result of two 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.

The citations in the county include:

Your plant did not have adequate sanitary facilities and accommodations.
You did not implement your allergen monitoring procedures.
Your written process corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control.

Both companies cited were involved in the Food and Cosmetics sector.

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.

Companies located within DeKalb County Cities and the citations they received in Q1

Company Name	Area of Business	Inspection Date	Issue Cited
Gate Gourmet #301	Food and Cosmetics	02/28/2024	Sanitary facilities and controls
Gate Gourmet #301	Food and Cosmetics	02/28/2024	Allergen preventive controls - Implement
Gate Gourmet #301	Food and Cosmetics	02/28/2024	Process preventive controls - Appropriate (Adequate)
Gate Gourmet #301	Food and Cosmetics	02/28/2024	Supply-chain program - Assurance (Adequate)
H-One Trading Corporation	Food and Cosmetics	01/30/2024	Qualifications of individuals
H-One Trading Corporation	Food and Cosmetics	01/30/2024	Sanitary operations - Plant maintenance
H-One Trading Corporation	Food and Cosmetics	01/30/2024	Hazard analysis - Identification of hazard
H-One Trading Corporation	Food and Cosmetics	01/30/2024	Supply-chain program - Establish
H-One Trading Corporation	Food and Cosmetics	01/30/2024	Signed and dated