FDA WARNING_LETTER - GE Healthcare Integrated IT Solution - May 13, 2008

This FDA Warning Letter, issued to GE Healthcare Integrated IT Solutions on October 2, 2008, details violations observed during an inspection from April 15 - May 13, 2008, concerning their Centricity Imaging and other Picture Archiving and Communication System (PACS) products. These products are classified as medical devices.

The inspection revealed that the devices are adulterated under Section 501(h) of the Act, as manufacturing, packing, storage, or installation methods do not conform to current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate procedures for analyzing quality data** (21 CFR 820.100(a)(1)), specifically regarding CAPA data sources and information from other GE Healthcare sites sharing product components. The firm's response was deemed inadequate, requiring submission of a retrospective review by July 31, 2008. 2. **Failure to establish and maintain adequate procedures for design changes** (21 CFR 820.30(i)), with examples of un-updated specifications and inaccurate release notes. The firm's response was inadequate, requiring submission of a retrospective review by August 31, 2008. 3. **Failure to establish and maintain adequate procedures