West Wake News

There were two companies in a city associated with Chatham County that received FDA citations as a result of two inspections conducted in the county throughout 2023, 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 year.

The citations in the county include:

• HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
• Procedures for corrective and preventive action have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

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
North Carolina Center for Reproductive Medicine, Inc.	Biologics	01/26/2023	Determination based on screening and testing
WatchChild, LLC	Devices	12/13/2023	Lack of or inadequate procedures
WatchChild, LLC	Devices	12/13/2023	Lack of or inadequate complaint procedures
WatchChild, LLC	Devices	12/13/2023	Statistical techniques - Lack of or inadequate procedures