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Wednesday, November 6, 2024

How many companies in cities across Durham County received FDA citations in 2023?

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James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

There were 11 companies in cities associated with Durham County that received FDA citations as a result of 11 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an 83.3% increase over the number of companies cited in the previous year.

Of the 38 citations issued, the most common citation was 'Risk analysis is inadequate'.

Most of the companies cited were involved in the Biologics sector. The second most common type of company cited in the time period worked in the either Devices or Food and Cosmetics 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.

Companies Located Within Durham 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
AmerisourceBergen Drug CorporationFood and Cosmetics06/15/2023Reserve sample - collect, hold
AmerisourceBergen Drug CorporationFood and Cosmetics06/15/2023Quality control operations - returned dietary supplement
AmerisourceBergen Drug CorporationFood and Cosmetics06/15/2023Written procedures - holding
AmerisourceBergen Drug CorporationFood and Cosmetics06/15/2023Written procedures - returned dietary supplement
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
Carolina Conceptions, PABiologics06/01/2023Determination based on screening and testing
Carolina Conceptions, PABiologics06/01/2023Labeled re: biohazard, risks, test results
CivaTech Oncology, Inc.Devices06/14/2023Design input - documentation
CivaTech Oncology, Inc.Devices06/14/2023Design Validation - Risk analysis not performed/inadequate
CivaTech Oncology, Inc.Devices06/14/2023Lack of or inadequate final acceptance procedures
CivaTech Oncology, Inc.Devices06/14/2023DHR - not or inadequately maintained
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
GlacierPoint Enterprises - CarolinasFood and Cosmetics07/20/2023Grounds
GlacierPoint Enterprises - CarolinasFood and Cosmetics07/20/2023Sanitary operations - Plant maintenance
GlacierPoint Enterprises - CarolinasFood and Cosmetics07/20/2023Plant operations - Precautions
GlacierPoint Enterprises - CarolinasFood and Cosmetics07/20/2023Storage and Distribution
Luminelle, Inc.Devices02/21/2023Individual Report of Malfunction
Luminelle, Inc.Devices02/21/2023Management review - defined interval, sufficient frequency
Luminelle, Inc.Devices02/21/2023Training records
Luminelle, Inc.Devices02/21/2023Design verification - Lack of or inadequate procedures
Luminelle, Inc.Devices02/21/2023Design Validation - Risk analysis not performed/inadequate
Luminelle, Inc.Devices02/21/2023Evaluation of suppliers, contractors, etc., requirements
Luminelle, Inc.Devices02/21/2023Lack of or inadequate complaint procedures
SpringWorks Therapeutics, Inc.Drugs03/31/2023General responsibilities of sponsors

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