Dorchester Today

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

This is an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend and a statement warning of the reactive test results.
• The abbreviated donor screening procedure was used for donors who had no complete donor screening procedure in the previous six months.
• A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus (CMV) was not established.

Both companies cited were involved in either Biologics 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
Piedmont Reproductive Endocrinology Associates Lowcountry	Biologics	08/07/2024	Labeled re: biohazard, risks, test results
Piedmont Reproductive Endocrinology Associates Lowcountry	Biologics	08/07/2024	Abbreviated procedure
Piedmont Reproductive Endocrinology Associates Lowcountry	Biologics	08/07/2024	SOP for release; reactive for CMV
Saffron, Inc.	Food and Cosmetics	08/22/2024	Sanitary operations - Plant maintenance
Saffron, Inc.	Food and Cosmetics	08/22/2024	Pest control
Saffron, Inc.	Food and Cosmetics	08/22/2024	Sanitation of food-contact surfaces - Frequency
Saffron, Inc.	Food and Cosmetics	08/22/2024	Hazard analysis - Conducted