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

Resilience US, Inc. in West Chester, OH, a manufacturer of sterile drug products, received a Form 483 with six observations highlighting significant deficiencies. The inspection revealed issues with procedures to prevent microbiological contamination, inadequate investigations into product discrepancies and batch failures, and problems with laboratory record-keeping and data integrity. These findings indicate a need for improved quality control and adherence to established manufacturing practices for sterile products.