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

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

This is a 30% decrease from the number of companies cited in the previous year.

The citations in the county include:

• An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• You did not submit an annual report by the September 1 deadline for products requiring one.
• You did not follow written quality assurance procedures.

Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the Food and Cosmetics sector.

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.