FDA issued 12 citations in cities across Hamilton County in 2024

There was one company in a city associated with Hamilton County that received FDA citations as a result of one inspection conducted in the county in 2024, according to the U.S. Food and Drug Administration (FDA).

This is an 83.3% decrease from the number of companies cited in the previous year.

The citations in the county include:

• The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
• Written MDR procedures have not been developed.
• The organizational structure has not been established and maintained to ensure that devices are designed in accordance with 21 CFR 820.

The company cited was involved in the Devices sector.

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.

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 and quality.