FDA 483 - Resilience US, Inc. - January 21, 2025

Resilience US, Inc., a drug manufacturer in West Chester, OH, received an FDA Form 483 following an inspection conducted from December 16, 2024, to January 21, 2025. The report detailed six observations indicating significant deviations from Current Good Manufacturing Practices (cGMP).

Primary violations included inadequate procedures to prevent microbiological contamination of sterile drug products. Specifically, the company lacked scientific justification for visual inspection defect types, failed to include critical defects like cloudy/turbid product in training, and did not document operator inspection times. Furthermore, the firm failed to thoroughly investigate unexplained discrepancies and batch failures, with multiple complaint and deviation investigations deemed insufficient for issues such as cloudy medication, particulate contamination, and AQL (Acceptance Quality Limit) failures.

Additional observations noted a lack of microbiological testing for incoming sterile drug product containers and closures. Laboratory records were deficient, lacking essential second-person review for accuracy in microbiology tests, and chromatography data manipulation without proper saving jeopardized data integrity. Finally, employees were observed failing to follow established written production and process control procedures, impacting aseptic practices and visual inspection processes. Resilience US, Inc. is required to provide a comprehensive response outlining its corrective and preventive actions to address these serious compliance issues.