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Kent County Today

Thursday, October 31, 2024

How many companies in cities across Kent County received FDA citations in 2023?

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

There were three companies in cities associated with Kent County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 200% increase over the number of companies cited in the previous year.

The citations in the county include:

  • Your hazard analysis did not identify a hazard that requires a control.
  • The organizational structure has not been established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
  • Design validation did not ensure the device conforms to defined user needs and intended uses.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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 Kent County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Sea Watch International, Ltd.Food and Cosmetics08/02/2023HACCP plan implementation
Tesla Biohealing, Inc.Devices03/23/2023Lack of or inadequate organizational structure
Tesla Biohealing, Inc.Devices03/23/2023Design validation - user needs and intended uses
Tesla Biohealing, Inc.Devices03/23/2023Evaluation and Selection, Suppliers, Contractors, etc.
Tesla Biohealing, Inc.Devices03/23/2023Equipment suitability & capability
VLM Foods USA, Ltd.Food and Cosmetics06/08/2023Hazard analysis biological, chemical, physical

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