FDA Warns GE Health Unit on Manufacturing Problems
Federal regulators have warned General Electric's health-care unit about manufacturing problems uncovered during an inspection of an Ohio plant, a letter released today said.
Food and Drug Administration inspectors found shortcomings at a GE Healthcare Technologies site in Aurora, Ohio, where the company makes coils used in magnetic resonance imaging systems and breast biopsy plates, the FDA said in the Feb. 22 letter.
General Electric is the parent company of CNBC.com.
The agency said the company's violations included a failure to assure that only devices approved for release were distributed. Employees also did not process complaints in a uniform and timely manner, the FDA said.
"You should take prompt action to correct the violations," said the letter, which was posted on the FDA Web site.
The FDA sends dozens of warning letters per year. Most issues raised are resolved without further action, but the letters can lead to product seizures, injunctions or other penalties.