West Wake News

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

This is a 400% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• You did not establish label specifications.
• You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.
• You did not establish and follow written procedures for quality control operations.

Most of the companies cited were involved in either Food and Cosmetics or Biologics sectors.

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
American Red Cross Blood Services	Biologics	10/16/2023	Backup data not assured as exact and complete
Avioq, Inc.	Biologics	12/05/2023	Identification procedures, Lack of or inadequate procedures
Avioq, Inc.	Biologics	12/05/2023	Lack of or inadequate procedures for storage.
Avioq, Inc.	Biologics	12/05/2023	DHR - not or inadequately maintained
North Lily Foods, Inc.	Food and Cosmetics	10/23/2023	Definition very small importer
Sweetbottoms Naturals, LLC	Food and Cosmetics	11/08/2023	Specifications - labels, packaging
Sweetbottoms Naturals, LLC	Food and Cosmetics	11/08/2023	Reserve sample - collect, hold
Sweetbottoms Naturals, LLC	Food and Cosmetics	11/08/2023	Written procedures - quality control operations
Sweetbottoms Naturals, LLC	Food and Cosmetics	11/08/2023	Written procedures - holding
Sweetbottoms Naturals, LLC	Food and Cosmetics	11/08/2023	Written procedures - returned dietary supplement
Sweetbottoms Naturals, LLC	Food and Cosmetics	11/08/2023	Written procedures - product complaint
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