FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - November 07, 2023

During an FDA inspection, primarily on November 2, 2023, drug manufacturer FDBT received an FDA Form 483 citing significant observations regarding its manufacturing and quality control operations. Key issues included widespread data integrity deficiencies, such as unprotected user access on critical pH meters, lack of independent Quality Assurance review of electronic data audit trails for production and QC systems, and incomplete laboratory records, including unrecorded "test injections" that impact data completeness. Furthermore, the company failed to back up raw electronic data from essential stand-alone instruments like pH meters and osmometers, with some data not backed up since 2019. The inspection also revealed that the manufacturing process for certain products was not adequately validated. This included unvalidated long-term storage conditions for chromatography media, lack of temperature control validation for material transport, and process validation studies not supported by consecutive lots due to inappropriate classification of equipment failures. Material management was found deficient, with multiple batches terminated due to contamination linked to material defects, for which corrective actions were still pending. Additional observations highlighted inconsistencies in information provided to the FDA regarding analytical method transfers, insufficient batch production records lacking critical process parameters like RPM settings, and an unassessed utility system location impacting product quality. To address these findings, FDBT must implement comprehensive corrective and preventive actions, focusing on strengthening data governance, completing process validation, improving contamination control, ensuring documentation accuracy, and conducting thorough quality risk assessments to comply with good manufacturing practices.