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Thursday, November 7, 2024

How many FDA citations were issued in cities within Orange County in Q4 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 Orange County that received FDA citations as a result of three inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% increase over the number of companies cited in the previous quarter.

The citations in the county 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 for which a specification was not met.
  • You did not follow written procedures for the requirements for components of dietary supplements.

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 Orange County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
CEMI International, Inc.Food and Cosmetics11/03/2023Component - verify identity, dietary ingredient
CEMI International, Inc.Food and Cosmetics11/03/2023Specifications not met - reject, quality control
CEMI International, Inc.Food and Cosmetics11/03/2023Written procedures - components
Hevener Sales, Inc.Food and Cosmetics10/24/2023Develop FSVP
Optimotion Implants, LLCDevices10/20/2023Product rework adverse effects {see also 820.184}

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