FDA: 4 companies in cities within Hall County received 8 citations in 2024

There were four companies in cities associated with Hall County that received FDA citations as a result of four inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 300% increase over the number of companies cited in the previous year.

The citations in the county include:

• Failure to provide adequate space for private and accurate examinations of individuals to determine their eligibility as blood donors.
• Equipment used in the collection and processing of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
• Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

All of the companies cited were involved in either Biologics, Drugs, 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.

According to its website, 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.