iVu Imaging Corporation – FDA Warning Letter, Apr 1, 2010

An FDA inspection of iVu Imaging Corporation, manufacturer of the Sofia® Automated Tomographic Ultrasound (ATUS) Imaging System, conducted from February to April 2010, revealed significant violations of Current Good Manufacturing Practice (CGMP) requirements under the Quality System (QS) regulation (21 CFR Part 820). The Sofia® system is classified as an adulterated medical device due to these non-conformities.

Key violations include: 1. **Design Validation (21 CFR § 820.30(g)):** Failure to establish and maintain procedures for validating device design. Specific issues included incomplete validation tests, lack of specific acceptance/rejection criteria for image quality in tests, insufficient testing across different product sizes, and validation not performed on production units or equivalents. 2. **Device History Records (DHR) (21 CFR § 820.184):** Failure to maintain DHRs to demonstrate manufacturing in accordance with the device master record. Examples included inaccurate serial numbers for distributed devices and failure to maintain all required images in performance check records. 3. **Installation Documentation (21 CFR § 820.170(b)):** Failure to document installation, inspection, and testing results for proper device installation. 4. **Device Master Records (DMR) (21 CFR § 820.181):** Incomplete DMRs, lacking device