Aiken Times

There was one company in a city associated with Edgefield County that received FDA citations as a result of one inspection conducted in the county throughout 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 year.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Halocarbon Life Sciences, LLC	Drugs	11/03/2023	Applicant did not submit/sent a late15-Day Initial alert report or wrong format
Halocarbon Life Sciences, LLC	Veterinary	11/03/2023	Applicant did not submit/sent a late15-Day Initial alert report or wrong format