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Thursday, October 31, 2024

How many companies in cities across Crockett 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 was one company in a city associated with Crockett County that received FDA citations as a result of one inspection conducted in the county throughout 2023, 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 year.

The citations in the county include:

  • You did not establish a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
  • You did not establish and follow written procedures for holding and distributing operations.
  • You did not establish and follow written procedures for when a returned dietary supplement is received.

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 Crockett County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Ozona Organics, LLCFood and Cosmetics06/29/2023Specifications - manufacturing process
Ozona Organics, LLCFood and Cosmetics06/29/2023Written procedures - holding
Ozona Organics, LLCFood and Cosmetics06/29/2023Written procedures - returned dietary supplement
Ozona Organics, LLCFood and Cosmetics06/29/2023Written procedures - product complaint

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