FDA: 1 company in cities within Seminole County received 7 citations in Q1

There was one company in a city associated with Seminole County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2026, according to the U.S. Food and Drug Administration (FDA).

This is a 66.7% decrease from the number of companies cited in the previous quarter.

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.
• The quality management system was not documented in accordance with applicable regulatory requirements.
• Top management did not ensure that applicable regulatory requirements were determined and met.

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.

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.