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East Arapahoe News

Wednesday, November 13, 2024

FDA issued 4 citations in cities across Douglas County in Q3

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Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

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

This is an increase over the number of companies cited in the previous quarter.

The citations in the county include:

  • The written MDR Procedure does not include an internal system which provides for timely and effective evaluation of events that may be subject to medical device reporting requirements.
  • An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
  • Risk analysis is inadequate.

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.

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 Douglas County Cities and the citations they received in Q3
Company NameArea of BusinessInspection DateIssue Cited
WalkMed, LLCDevices09/13/2024Lack of System for Event Evaluations
WalkMed, LLCDevices09/13/2024Individual Report of Malfunction
WalkMed, LLCDevices09/13/2024Design Validation - Risk analysis not performed/inadequate
WalkMed, LLCDevices09/13/2024Lack of or inadequate complaint procedures

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