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Durham Reporter

Thursday, October 31, 2024

FDA: 6 companies in cities within Orange County received 17 citations in 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

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.

Companies Located Within Orange County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
American Red Cross Blood ServicesBiologics10/16/2023Backup data not assured as exact and complete
Avioq, Inc.Biologics12/05/2023Identification procedures, Lack of or inadequate procedures
Avioq, Inc.Biologics12/05/2023Lack of or inadequate procedures for storage.
Avioq, Inc.Biologics12/05/2023DHR - not or inadequately maintained
Biogen U. S. CorporationBiologics10/17/2023Control procedures to monitor and validate performance
Biogen U. S. CorporationBiologics10/17/2023Procedures for sterile drug products
Biogen U. S. CorporationBiologics10/17/2023Scientifically sound laboratory controls
Biogen U. S. CorporationBiologics10/17/2023Investigations of discrepancies, failures
Biogen U. S. CorporationBiologics10/17/2023Procedures to be written and followed
Bleep, LLCDevices08/25/2023Lack of or inadequate organizational structure
Bleep, LLCDevices08/25/2023Design plans - Lack of or inadequate
Bleep, LLCDevices08/25/2023Design changes - Lack of or Inadequate Procedures
Bleep, LLCDevices08/25/2023Purchasing controls, Lack of or inadequate procedures
Bleep, LLCDevices08/25/2023Documentation
Concept Food Services Distributors, Inc.Food and Cosmetics08/03/2023Hazard analysis biological, chemical, physical
Concept Food Services Distributors, Inc.Food and Cosmetics08/03/2023Approved supplier procedures - importer established
SpringWorks Therapeutics, Inc.Drugs03/31/2023General responsibilities of sponsors

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