Unresolved Manufacturing Facility Deficiencies
Severity: criticalFollowing a pre-license inspection of Samsung Biologics Co., Ltd., FDA conveyed deficiencies. Responses from the facility have been reviewed, but not all deficiencies are satisfactorily resolved. Satisfactory responses are required from the facility prior to submitting the complete response.
Recommended response: Collaborate closely with the manufacturing facility to ensure all outstanding inspectional observations are fully addressed and satisfactory responses are provided to the FDA before resubmitting the application.
Concerns Regarding Data Reliability from Manufacturing Site
Severity: criticalEvaluation of inspection findings and responses identified concerns regarding the reliability of data generated at Samsung Biologics. These concerns impact data supporting drug substance and drug product manufacturing process validation and characterization, preventing determination of the adequacy of the manufacturing process and overall control strategy.
Recommended response: Conduct a thorough investigation into the data integrity issues, re-evaluate all impacted data, and provide reliable and accurate information, potentially including results from repeated studies, to support consistent process performance and product quality.
Medication Guide Statement Requirement
Severity: majorAdd the bolded statement 'ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.' or an appropriate alternative to the carton and container labeling.
Recommended response: Revise the carton and container labeling to include the mandatory Medication Guide statement as specified by the regulation.
Cited: 21 CFR 208.24(d)
Proprietary Name Resubmission Required
Severity: minorThe proposed proprietary name, Unloxcyt, was found conditionally acceptable pending approval of the application. It must be resubmitted when all application deficiencies have been identified and addressed.
Recommended response: Prepare to resubmit the proprietary name request once all other deficiencies in the application have been fully resolved.
Comprehensive Safety Update Required
Severity: majorInclude a comprehensive safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies. This includes detailed descriptions of significant changes/findings, incorporation of new safety data (tabulations, comparisons), separate tables for adverse events for other indications, case report forms/narratives for deaths/discontinuations due to AEs, narrative summaries for serious AEs, updated exposure information, worldwide safety experience summary, and English translations of foreign labeling.
Recommended response: Compile a thorough and compliant safety update, integrating all new clinical data, providing detailed analyses, narratives, and a summary of worldwide experience as per regulatory guidelines.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
