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Wednesday, November 20, 2024

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

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

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

This is a 28.6% decrease from the number of companies cited in the previous year.

The citations in the county include:

  • You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
  • You did not verify that your finished batch of dietary supplement meets product specifications for limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement.
  • Your quality control personnel did not reject a component when an established specification was not met.

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

All of the 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 Lane County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
EarthLab, Inc.Food and Cosmetics04/24/2023Specifications - identity, purity, strength, composition
Juanita's Snacks, LLCFood and Cosmetics03/31/2023Personnel
Mountain Rose, Inc.Food and Cosmetics12/15/2023Specifications met - verify; finished batch
Mountain Rose, Inc.Food and Cosmetics12/15/2023Quality control - reject; specification not met
Mountain Rose, Inc.Food and Cosmetics12/15/2023Hazard analysis - Identification of hazard
Thistledown Farm, Inc.Food and Cosmetics08/25/2023Training for supervisors
Thistledown Farm, Inc.Food and Cosmetics08/25/2023Training records
Thistledown Farm, Inc.Food and Cosmetics08/25/2023Equip & tools - cleanability
Thistledown Farm, Inc.Food and Cosmetics08/25/2023Toilet facilities - prevent contamination
Thistledown Farm, Inc.Food and Cosmetics08/25/2023Records - equipment cleaning and sanitizing
Thistledown Farm, Inc.Food and Cosmetics08/25/2023Record requirements
Toby's Family Foods, LLCFood and Cosmetics08/24/2023Process preventive controls - Implement
Toby's Family Foods, LLCFood and Cosmetics08/24/2023HACCP plan not implemented
Toby's Family Foods, LLCFood and Cosmetics08/24/2023Verification activities - minimum
Toby's Family Foods, LLCFood and Cosmetics08/24/2023Process controls - HACCP plan - 5 log reduction

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