How many companies in cities across Morris County received FDA citations in Q4 2024?

There were two companies in cities associated with Morris County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 2024, 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 include:

• An application holder did not make training available to prescribing healthcare providers (HCPs), as required by your approved REMS Element to Assure Safe Use (ETASU) A.
• An application holder did not ensure mechanisms are in place that allow pharmacies the ability to complete the certification process, as required by your approved REMS Element to Assure Safe Use (ETASU) B.
• An application holder did not instruct healthcare providers or health care facilities to monitor patients after administration of the drug, as required by your approved REMS Element to Assure Safe Use (ETASU) E.

Both 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.