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Wednesday, November 6, 2024

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

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James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

There were three companies in cities associated with Marion 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 unchanged from the number of companies cited in the previous year.

Of the 12 citations issued, the most common citations include:

  • You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
  • Your quality control personnel did not reject a component when an established specification was not met.
  • You did not identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification was met.

Most 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 Marion County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
E. Z. Orchards, Inc.Food and Cosmetics09/01/2023Pest contamination in buildings
E. Z. Orchards, Inc.Food and Cosmetics09/01/2023Plumbing size, design, installation, and maintenance
Highland Laboratories, Inc.Food and Cosmetics03/10/2023Component - verify identity, dietary ingredient
Highland Laboratories, Inc.Food and Cosmetics03/10/2023Quality control - reject; specification not met
Highland Laboratories, Inc.Food and Cosmetics03/10/2023Examination, testing; scientifically valid
Highland Laboratories, Inc.Food and Cosmetics03/10/2023Quality control production, process control; material review, disposition
Highland Laboratories, Inc.Veterinary03/10/2023Component - verify identity, dietary ingredient
Highland Laboratories, Inc.Veterinary03/10/2023Quality control - reject; specification not met
Highland Laboratories, Inc.Veterinary03/10/2023Examination, testing; scientifically valid
Highland Laboratories, Inc.Veterinary03/10/2023Quality control production, process control; material review, disposition
Lucas & Son, Inc.Food and Cosmetics07/20/2023Food contact surface sanitary inspection and maintenance
Lucas & Son, Inc.Food and Cosmetics07/20/2023Domesticated animal excreta and litter

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