Winston Salem Times

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

This is unchanged from the number of companies cited in the previous year.

Of the 15 citations issued, the most common citation was 'You did not conduct and document your hazard analysis'.

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
Batistini USA, LLC	Food and Cosmetics	04/27/2023	Sanitary operations - Plant maintenance
Batistini USA, LLC	Food and Cosmetics	04/27/2023	Pest control
Carolina Cookie Company	Food and Cosmetics	10/10/2023	Hazard analysis - Conducted
Carolon Company	Devices	06/15/2023	Lack of System for Event Evaluations
Carolon Company	Devices	06/15/2023	Results of evaluation not in mfr's MDR file
Carolon Company	Devices	06/15/2023	Quality Audit/Reaudit - conducted
Carolon Company	Devices	06/15/2023	Nonconforming product, Lack of or inadequate procedures
Carolon Company	Devices	06/15/2023	Lack of or inadequate procedures
Carolon Company	Devices	06/15/2023	DHR - not or inadequately maintained
Carolon Company	Devices	06/15/2023	Lack of or inadequate complaint procedures
CorneaGEn, Inc.	Biologics	05/31/2023	Monitoring--cross contamination, exposure to CD
CorneaGEn, Inc.	Biologics	05/31/2023	Verification elements
Moravian Sugar Crisp Company, Inc.	Food and Cosmetics	08/03/2023	Hazard analysis - Conducted
Moravian Sugar Crisp Company, Inc.	Food and Cosmetics	08/03/2023	Other preventive controls - Implement
Moravian Sugar Crisp Company, Inc.	Food and Cosmetics	08/03/2023	Other preventive controls - Record review