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Washington (ChatterShmatter) – The Food and Drug Administration (FDA) have issued a warning to GE Healthcare’s Integrated IT Solutions unit due to poor record keeping and other forms of manufacturing errors.
The company, located in Barrington, Illinois, is responsible for the production of numerous computer parts, including software systems for medical imaging devices.
The plant had been inspected in April and the company had worked on what the FDA had found lacking, but according to officials with the agency, not enough was done, thus the warning letter was sent.
The FDA can fine, or close down companies that lack proper guidelines, but usually once warning letters are issued, the problems are quickly rectified.
“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.
