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Wednesday, November 6, 2024

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

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

There were four companies in cities associated with Deschutes County that received FDA citations as a result of four inspections conducted in the county throughout 2023, 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 year.

Of the 14 citations issued, the most common citations include:

  • You did not establish component specifications for purity, strength and composition.
  • You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.
  • You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).

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 Deschutes County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Metabolic Maintenance ProductsFood and Cosmetics06/14/2023Specifications-component purity, strength, composition
Metabolic Maintenance ProductsFood and Cosmetics06/14/2023Specifications - contamination limits
Metabolic Maintenance ProductsFood and Cosmetics06/14/2023Specifications - identity, purity, strength, composition
Metabolic Maintenance ProductsFood and Cosmetics06/14/2023Quality control - batch, product specifications
Metabolic Maintenance ProductsFood and Cosmetics06/14/2023Record - product complaint; findings
Oregons Wild Harvest, Inc.Food and Cosmetics02/06/2023Tests, examinations - scientifically valid
Personalized NutrientsFood and Cosmetics06/07/2023Specifications - component identity
Personalized NutrientsFood and Cosmetics06/07/2023Specifications-component purity, strength, composition
Personalized NutrientsFood and Cosmetics06/07/2023Specifications - contamination limits
Personalized NutrientsFood and Cosmetics06/07/2023Specifications - identity, purity, strength, composition
Personalized NutrientsFood and Cosmetics06/07/2023Specifications met - contamination limits
ReNovo, Inc.Devices05/18/2023Environmental control Lack of or inadequate procedures
ReNovo, Inc.Devices05/18/2023Periodic equipment inspection lack of or inadequate procedu
ReNovo, Inc.Devices05/18/2023Nonconforming product, Lack of or inadequate procedures

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