On August 12, the Food and Drug Administration (FDA) sent a warning letter to the Integrated IT Solutions business unit of GE Healthcare, Waukesha, Wis. The letter informed GE of 12 violations of current good manufacturing practices (cGMPs) at its Barrington, Ill site, where Centricity PACS software is manufactured and distributed.

Some of the violations cited by the FDA include failure to establish and maintain adequate procedures for analyzing processes, work operations, concessions, and more; failure to establish and maintain adequate procedures for identifying, documenting and verifying design changes prior to their implementation; failure to submit a written report to the FDA of all corrections or removals of devices initiated by the manufacturer; and more.

GE said it is working aggressively to address these issues; failure to correct them in a timely manner could result in seizure, injunction, or monetary penalties.