Chapel Hill Review

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

This is a 500% increase over the number of companies cited in the previous year.

The citations in the county include:

• The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
• Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
• Procedures for design change have not been adequately established.

Most of the companies cited were involved in the Biologics 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
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
Bleep, LLC	Devices	08/25/2023	Lack of or inadequate organizational structure
Bleep, LLC	Devices	08/25/2023	Design plans - Lack of or inadequate
Bleep, LLC	Devices	08/25/2023	Design changes - Lack of or Inadequate Procedures
Bleep, LLC	Devices	08/25/2023	Purchasing controls, Lack of or inadequate procedures
Bleep, LLC	Devices	08/25/2023	Documentation
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
SpringWorks Therapeutics, Inc.	Drugs	03/31/2023	General responsibilities of sponsors