FDA 483 - Dimension Inx Corp. - February 27, 2025

Dimension Inx Corp., a medical device manufacturer in Chicago, was cited for two observations during an FDA inspection from February 25-27, 2025. The firm failed to adequately validate the sterilization process for its CMFlex medical device, specifically lacking a completed performance qualification. Additionally, the company has not established adequate procedures for sampling methods, including a statistical rationale for its manufacturing performance qualification study.