# FDA WARNING_LETTER - iVu Imaging Corporation - April 01, 2010

Source: https://www.keypedia.com/records/warning_letter/ivu-imaging-corporation/10d46260-b066-4384-a06d-1f97bfbcf94c

> FDA WARNING_LETTER for iVu Imaging Corporation on April 01, 2010. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: iVu Imaging Corporation
- Inspection Date: 2010-04-01
- Product Type: Devices
- Office Name: Dallas District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.keypedia.com/companies/ivu-imaging-corporation/6be2f358-2357-4c13-a19e-e74d2c5adcd0

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9