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Wednesday, November 6, 2024

How many companies in cities across Fulton County received FDA 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 eight companies in cities associated with Fulton County that received FDA citations as a result of eight inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 57.9% decrease from the number of companies cited in the previous year.

Of the 27 citations issued, the most common citations include:

  • The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
  • Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
  • There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

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

Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).

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 Fulton County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Acella Pharmaceuticals, LLCDrugs02/10/2023Approve or reject procedures or specs
Acella Pharmaceuticals, LLCDrugs02/10/2023Scientifically sound laboratory controls
Acella Pharmaceuticals, LLCDrugs02/10/2023Investigations of discrepancies, failures
Acella Pharmaceuticals, LLCDrugs02/10/2023Procedures to be written and followed
Avanos Medical, Inc.Devices12/15/2023Design Validation - Risk analysis not performed/inadequate
Avanos Medical, Inc.Devices12/15/2023Lack of or inadequate procedures
Avanos Medical, Inc.Devices12/15/2023Lack of or inadequate complaint procedures
Avion Pharmaceuticals, LLCDrugs11/08/2023Procedures not in writing, fully followed
Avion Pharmaceuticals, LLCDrugs11/08/2023Control procedures to monitor and validate performance
Avion Pharmaceuticals, LLCDrugs11/08/2023Investigations of discrepancies, failures
Avion Pharmaceuticals, LLCDrugs11/08/2023Returned drug procedures in writing and followed
Dester CorporationFood and Cosmetics03/23/2023Develop FSVP
Dynamic Technical Formulations, LLCFood and Cosmetics08/22/2023Specifications - component identity
Dynamic Technical Formulations, LLCFood and Cosmetics08/22/2023Specifications met - identity, purity, strength, composition
Dynamic Technical Formulations, LLCFood and Cosmetics08/22/2023Records - ret'nd dietary supplement: material review, dispos
Kor- Chem, Inc.Drugs05/05/2023Procedures not in writing, fully followed
Kor- Chem, Inc.Drugs05/05/2023Training--operations, GMPs, written procedures
Kor- Chem, Inc.Drugs05/05/2023Reports of Analysis (Components)
Kor- Chem, Inc.Drugs05/05/2023Control procedures to monitor and validate performance
Kor- Chem, Inc.Drugs05/05/2023Expiration date lacking
Kor- Chem, Inc.Drugs05/05/2023Scientifically sound laboratory controls
Kor- Chem, Inc.Drugs05/05/2023Microbiological testing
Kor- Chem, Inc.Drugs05/05/2023Specific information required in individual logs
Kor- Chem, Inc.Drugs05/05/2023Complete instructions, procedures, specifications et. al.
Kor- Chem, Inc.Drugs05/05/2023Investigations of discrepancies, failures
O&M Halyard, Inc.Devices04/27/2023Individual Report of Malfunction
San Antonio Bakery Solutions, LLCFood and Cosmetics03/15/2023Develop FSVP

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