FDA 483 - Charles River Laboratories Inc - October 11, 2024

Charles River Laboratories, Inc., a cell and gene therapy establishment in Memphis, TN, underwent an FDA inspection from October 7-11, 2024. The inspection resulted in an FDA Form 483, detailing significant observations indicating non-compliance with regulatory expectations for pharmaceutical manufacturing.

The primary issues identified included deficient Quality Assurance oversight, particularly in the timely management of deviations. The firm was observed to have delays in initiating, investigating, and closing deviations, as well as in implementing corrective actions. Examples included critical temperature units used for materials not being requalified for several years, and critical deviation investigations remaining open past permitted extensions.

Moreover, the FDA noted that environmental controls and manufacturing processes were insufficient to ensure product sterility. This was demonstrated by multiple product microbial contamination events coinciding with numerous environmental monitoring excursions in critical production areas. Preventative actions were not identified or effectively implemented, and a critical raw material lacked a validated sterilization process. Additionally, the firm's procedures for testing and qualifying raw materials were found to be deficient, as certain components were used in manufacturing without required post-receipt testing.

Charles River Laboratories is required to provide a comprehensive response detailing corrective and preventive actions to address these observations and ensure compliance with the Federal Food, Drug and Cosmetic Act and associated regulations.