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 first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 66.7% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Procedures have not been adequately established to control product that does not conform to specified requirements.
• Procedures for corrective and preventive action have not been adequately established.
• Complaint files are not adequately maintained.

Most of the companies cited were involved in the Drugs sector.

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
BioDuro, LLC	Drugs	02/23/2024	Procedures not in writing, fully followed
BioDuro, LLC	Drugs	02/23/2024	Equipment Design, Size and Location
BioDuro, LLC	Drugs	02/23/2024	Absence of Written Procedures
BioDuro, LLC	Drugs	02/23/2024	Scientifically sound laboratory controls
BioDuro, LLC	Drugs	02/23/2024	Testing and release for distribution
BioDuro, LLC	Drugs	02/23/2024	Acceptance criteria for sampling & testing
BioDuro, LLC	Drugs	02/23/2024	Records reviewed annually
BioDuro, LLC	Drugs	02/23/2024	Investigations of discrepancies, failures
Biogennix, LLC	Devices	02/08/2024	Nonconforming product, Lack of or inadequate procedures
Biogennix, LLC	Devices	02/08/2024	Lack of or inadequate procedures
Biogennix, LLC	Devices	02/08/2024	Complaints
Children's Hospital of Orange County	Biologics	01/16/2024	Establish, maintain and follow manufacturing SOPs
Children's Hospital of Orange County	Biologics	01/16/2024	Concurrent documentation
Flavorchem Corporation	Food and Cosmetics	02/07/2024	Plant operations - Precautions
LGM Pharma Solutions, LLC	Drugs	03/01/2024	Procedures not in writing, fully followed
LGM Pharma Solutions, LLC	Drugs	03/01/2024	Written procedures not established/followed
LGM Pharma Solutions, LLC	Drugs	03/01/2024	Absence of Written Procedures
LGM Pharma Solutions, LLC	Drugs	03/01/2024	Deviations from laboratory control requirements