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Portland Courant

Thursday, November 21, 2024

FDA: 2 companies in cities within Washington County received 4 citations in Q1

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

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

This is a 50% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

  • Procedures for design change have not been established.
  • Procedures for corrective and preventive action have not been adequately established.
  • A device master record has not been adequately maintained.

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.

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, according to its website.

Companies located within Washington County Cities and the citations they received in Q1
Company NameArea of BusinessInspection DateIssue Cited
Global Importing Group, Inc.Food and Cosmetics01/08/2024Develop FSVP
US Vascular, LLCDevices03/06/2024Design changes - Lack of or Inadequate Procedures
US Vascular, LLCDevices03/06/2024Lack of or inadequate procedures
US Vascular, LLCDevices03/06/2024DMR - not or inadequately maintained

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