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Central Broward News

Tuesday, April 22, 2025

FDA: 1 company in cities within Broward County received 8 citations in March

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

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

This is unchanged from the number of companies cited in the previous month.

The citations in the county include:

  • Procedures for management review have not been adequately established.
  • Procedures for quality audits have not been adequately established.
  • Personnel training is not documented.

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 quality.

Companies located within Broward County Cities and the citations they received in March
Company NameArea of BusinessInspection DateIssue Cited
OMT, LLCDevices03/05/2025Management review - Lack of or inadequate procedures
OMT, LLCDevices03/05/2025Quality audits - Lack of or inadequate procedures
OMT, LLCDevices03/05/2025Training records
OMT, LLCDevices03/05/2025Design validation- Lack of or inadequate procedures
OMT, LLCDevices03/05/2025Purchasing controls, Lack of or inadequate procedures
OMT, LLCDevices03/05/2025Environmental control Lack of or inadequate procedures
OMT, LLCDevices03/05/2025Documentation
OMT, LLCDevices03/05/2025Lack of or inadequate procedures

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