FDA 483 - Catalent Pharma Solutions LLC - December 15, 2022

During an FDA inspection conducted from December 5-15, 2022, Catalent Pharma Solutions LLC, a manufacturer and contract testing lab located in Morrisville, NC, received a Form 483 detailing significant observations. These observations indicate deviations from current Good Manufacturing Practices (cGMP) related to their laboratory control systems.

Key issues included the absence of written test procedures for critical steps in pyrogen testing, specifically lacking instructions for product mixing during endotoxin assays. Furthermore, essential laboratory instruments, such as (b)(4) units, a microscope, and (b)(4) pumps used for endotoxin, sterility, and organism identification, were found to be uncalibrated, with no established calibration procedures. The firm also failed to properly validate certain test methods, including a disinfection procedure for sterility samples, and did not adhere to United States Pharmacopeia (USP) guidelines by using media control instead of negative controls for microbiological examinations.

Additionally, the inspection revealed a failure to consistently follow established laboratory control mechanisms, such as incorrect incubation conditions for sterility tests and not performing (b)(4) testing on incoming media lots used for product release, stability, and environmental monitoring. Catalent Pharma Solutions LLC is required to respond with a detailed plan outlining comprehensive corrective and preventive actions to address these noted quality system deficiencies.