West Wake News

There were 14 companies in cities associated with Wake County that received FDA citations as a result of 14 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.

Of the 44 citations issued, the most common citations include:

• 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 holding and distributing operations.
• You did not establish and follow written procedures for when a returned dietary supplement is received.

Most of the companies cited were involved in either Food and Cosmetics or Biologics sectors. The second most common type of company cited in the time period worked in the the Devices 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
American Red Cross Blood Services	Biologics	10/16/2023	Backup data not assured as exact and complete
AmerisourceBergen Drug Corporation	Food and Cosmetics	06/15/2023	Reserve sample - collect, hold
AmerisourceBergen Drug Corporation	Food and Cosmetics	06/15/2023	Quality control operations - returned dietary supplement
AmerisourceBergen Drug Corporation	Food and Cosmetics	06/15/2023	Written procedures - holding
AmerisourceBergen Drug Corporation	Food and Cosmetics	06/15/2023	Written procedures - returned dietary supplement
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
Biogen U. S. Corporation	Biologics	10/17/2023	Control procedures to monitor and validate performance
Biogen U. S. Corporation	Biologics	10/17/2023	Procedures for sterile drug products
Biogen U. S. Corporation	Biologics	10/17/2023	Scientifically sound laboratory controls
Biogen U. S. Corporation	Biologics	10/17/2023	Investigations of discrepancies, failures
Biogen U. S. Corporation	Biologics	10/17/2023	Procedures to be written and followed
Carolina Conceptions, PA	Biologics	06/01/2023	Determination based on screening and testing
Carolina Conceptions, PA	Biologics	06/01/2023	Labeled re: biohazard, risks, test results
CivaTech Oncology, Inc.	Devices	06/14/2023	Design input - documentation
CivaTech Oncology, Inc.	Devices	06/14/2023	Design Validation - Risk analysis not performed/inadequate
CivaTech Oncology, Inc.	Devices	06/14/2023	Lack of or inadequate final acceptance procedures
CivaTech Oncology, Inc.	Devices	06/14/2023	DHR - not or inadequately maintained
Concept Food Services Distributors, Inc.	Food and Cosmetics	08/03/2023	Hazard analysis biological, chemical, physical
Concept Food Services Distributors, Inc.	Food and Cosmetics	08/03/2023	Approved supplier procedures - importer established
GlacierPoint Enterprises - Carolinas	Food and Cosmetics	07/20/2023	Grounds
GlacierPoint Enterprises - Carolinas	Food and Cosmetics	07/20/2023	Sanitary operations - Plant maintenance
GlacierPoint Enterprises - Carolinas	Food and Cosmetics	07/20/2023	Plant operations - Precautions
GlacierPoint Enterprises - Carolinas	Food and Cosmetics	07/20/2023	Storage and Distribution
Luminelle, Inc.	Devices	02/21/2023	Individual Report of Malfunction
Luminelle, Inc.	Devices	02/21/2023	Management review - defined interval, sufficient frequency
Luminelle, Inc.	Devices	02/21/2023	Training records
Luminelle, Inc.	Devices	02/21/2023	Design verification - Lack of or inadequate procedures
Luminelle, Inc.	Devices	02/21/2023	Design Validation - Risk analysis not performed/inadequate
Luminelle, Inc.	Devices	02/21/2023	Evaluation of suppliers, contractors, etc., requirements
Luminelle, Inc.	Devices	02/21/2023	Lack of or inadequate complaint procedures
North Carolina Center for Reproductive Medicine, Inc.	Biologics	01/26/2023	Determination based on screening and testing
North Lily Foods, Inc.	Food and Cosmetics	10/23/2023	Definition very small importer
SpringWorks Therapeutics, Inc.	Drugs	03/31/2023	General responsibilities of sponsors
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