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Central OC Times

Wednesday, November 6, 2024

How many companies in cities across Orange County received FDA citations in September?

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Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

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

This is unchanged from the number of companies cited in the previous month.

The citations in the county include:

  • You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
  • You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
  • You did not determine and document which verification activity or activities were needed to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.

Both 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 September
Company NameArea of BusinessInspection DateIssue Cited
Micro Precision SwissDevices09/12/2024Lack of or inadequate In-process acceptance procedures
Micro Precision SwissDevices09/12/2024Lack of or inadequate procedures
Pura Vida Farms, LLCFood and Cosmetics09/10/2024Evaluation - performance, risk
Pura Vida Farms, LLCFood and Cosmetics09/10/2024Supplier verification - establish written procedures
Pura Vida Farms, LLCFood and Cosmetics09/10/2024Verification activity assurance

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