August 19, 2008 / 2:51 PM / 11 years ago

UPDATE 2-U.S. FDA warns GE Healthcare unit over records

(Adds GE response, background)

By Susan Heavey

WASHINGTON, Aug 19 (Reuters) - The U.S. Food and Drug Administration has warned GE Healthcare’s Integrated IT Solutions unit about a dozen manufacturing violations including improper record keeping that could result in further action from the agency.

The unit, which makes various computer and software systems to support medical imaging devices, also did not to establish adequate procedures to review products, the FDA said in a warning letter dated Aug. 12 and released on Tuesday.

The FDA issues dozens of similar warning letters every year. It can impose fines and take other punitive action, though most complaints are resolved without penalty.

An FDA inspection of the IT unit’s facility in Barrington, Illinois, in April and May turned up 12 complaints, the letter said.

Most cite the company’s failure to set up proper methods to ensure product quality and handle complaints.

Officials from the IT unit had responded in June to the FDA over the complaints, but some of the company’s corrective actions were “inadequate,” the agency wrote.

“GE Healthcare takes the warning letter very seriously, and is actively working on providing the information requested by FDA in the warning letter and on identifying further enhancements to the site’s quality systems that may be appropriate,” said Brian McKaig, a spokesman for General Electric Co (GE.N)’s Healthcare arm, in an e-mailed statement.

The IT unit has 15 days to tell the agency how it plans to fix the procedural problems and prevent future ones, according to the letter, which was posted on the FDA's website here

A GE factory in Salt Lake City, Utah, that makes X-ray machines had to stop shipments from late 2006 through May 2008 after the FDA raised quality-control concerns. That facility has since resumed shipping equipment. (Additional reporting by Scott Malone in Boston, editing by Tim Dobbyn and Daniel Trotta)

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