FDA 483 - Resilience Boston Inc. - February 16, 2024

The U.S. Food and Drug Administration (FDA) conducted an inspection of Resilience US, Inc., a Cell and Gene Therapy Contract Manufacturer located in Durham, NC, from February 12 to 16, 2024. This inspection, carried out by the Center for Biologics Evaluation and Research (CBER), resulted in the issuance of a Form FDA 483, detailing multiple observations related to the company's adherence to Good Manufacturing Practices. Key findings included significant procedural inadequacies in deviation management. The firm's system allowed corrections, missing signatures, or transcription errors without initiating a deviation or providing explanations. Additionally, procedures for trending similar deviations, such as missing product or incorrect materials, were deemed insufficient. The FDA also noted the absence of defined procedures for retesting Out-of-Specification results, lacking clear guidelines on the number of retests permitted and final result calculations. Further observations cited a deficient disinfectant efficacy study, which did not include all necessary organisms to demonstrate effectiveness. Finally, the inspection uncovered deficiencies in testing incoming components, specifically the lack of essential verification tests for container closures and inadequate testing of other critical raw materials. Resilience US, Inc. is required to address these observations by developing and implementing comprehensive corrective actions to ensure full compliance with regulatory requirements.