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

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

By North OC Times

Oct 2, 2024

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 Name	Area of Business	Inspection Date	Issue Cited
Micro Precision Swiss	Devices	09/12/2024	Lack of or inadequate In-process acceptance procedures
Micro Precision Swiss	Devices	09/12/2024	Lack of or inadequate procedures
Pura Vida Farms, LLC	Food and Cosmetics	09/10/2024	Evaluation - performance, risk
Pura Vida Farms, LLC	Food and Cosmetics	09/10/2024	Supplier verification - establish written procedures
Pura Vida Farms, LLC	Food and Cosmetics	09/10/2024	Verification activity assurance