Central OC Times

There were five companies in cities associated with Orange County that received FDA citations as a result of five inspections conducted in the county over the fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
• Procedures for design transfer have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

Most of the companies cited were involved in either Biologics or Food and Cosmetics sectors.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
EM Tortillas, LLC	Food and Cosmetics	11/05/2024	Sanitary operations - Plant maintenance
EM Tortillas, LLC	Food and Cosmetics	11/05/2024	Sanitary facilities and controls
EM Tortillas, LLC	Food and Cosmetics	11/05/2024	Food safety plan
Fertility Care of Orange County, A Medical Corporation	Biologics	10/07/2024	Risk factors, clinical evidence
Huntington Reproductive Center Medical Group	Biologics	10/29/2024	Determination based on screening and testing
Huntington Reproductive Center Medical Group	Biologics	10/29/2024	Name and personal info on accompanying records
M. R. S. Foods, Inc.	Food and Cosmetics	10/04/2024	Personnel
M. R. S. Foods, Inc.	Food and Cosmetics	10/04/2024	Sanitation of food-contact surfaces - Frequency
M. R. S. Foods, Inc.	Food and Cosmetics	10/04/2024	Equipment and utensils - Design and maintenance
Medicatech Usa	Devices	10/22/2024	Design transfer - Lack of or inadequate procedures
Medicatech Usa	Devices	10/22/2024	Lack of or inadequate complaint procedures
Medicatech Usa	Devices	10/22/2024	Devices subject to device identification GUDID data submission requirements.