FDA: 2 companies in cities within Hudson County received 10 citations in November 2024

FDA: 2 companies in cities within Hudson County received 10 citations in November 2024
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA — Official Website
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There were two companies in a city associated with Hudson County that received FDA citations as a result of two inspections conducted in the county in November 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous month.

The citations in the county include:

  • You did not implement the monitoring procedures listed in your HACCP plan.
  • Written MDR procedures have not been implemented.
  • Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.

The companies cited were involved in either Food and Cosmetics or Devices sectors.

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.

Companies located within Hudson County Cities and the citations they received in November 2024
Company Name Area of Business Inspection Date Issue Cited
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 Lack of Written MDR Procedures
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 Management review – defined interval, sufficient frequency
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 Quality audits – Lack of or inadequate procedures
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 Training records
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 Design validation – Risk analysis
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 Purchasing controls, Lack of or inadequate procedures
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 Production processes
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 Documentation
George Taub Products & Fusion Company, Inc. Devices 11/20/2024 DMR – not or inadequately maintained
Yama Seafood, Inc. Food and Cosmetics 11/15/2024 HACCP plan implementation


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