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Aiken Times

Thursday, November 21, 2024

FDA issued 2 citations in cities across Aiken County in Q4 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

There was one company in a city associated with Aiken County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous quarter.

The citations in the county were 'You did not submit a 15-Day NADA/ANADA alert report of adverse drug events that are both serious and unexpected within 15 working days of first receiving the information to FDA'.

The company cited should take a voluntary action to correct its 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 Aiken County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Halocarbon Life Sciences, LLCDrugs11/03/2023Applicant did not submit/sent a late15-Day Initial alert report or wrong format
Halocarbon Life Sciences, LLCVeterinary11/03/2023Applicant did not submit/sent a late15-Day Initial alert report or wrong format

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