Central OC Times

There was one company in a city associated with Orange County that received FDA citations as a result of one inspection conducted in the county in March, 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 month.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

The company cited should take a voluntary action to correct its 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
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