FDA 483 - Infinity Labs SD, Inc - August 21, 2023

Infinity Labs SD, Inc., a contract sterilizer in San Jose, CA, received a Form FDA 483 for inadequate documentation of corrective and preventive action (CAPA) activities. The inspection found that CAPA investigations frequently attributed issues to "operator error" without adequately documenting reviews of products, processes, or the overall quality system. This deficiency indicates a need for more thorough root cause analysis and documentation within the firm's quality management system.