Dorchester Today

There was one company in a city associated with Charleston County that received FDA citations as a result of one inspection conducted in the county in August, 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 month.

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.

The company cited should take a voluntary action to correct its 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