A Johnson & Johnson unit failed to properly investigate and report complaints about certain devices used by diabetics to measure blood sugar, U.S. regulators charged in a letter made public Tuesday.
The Food and Drug Administration said it uncovered that problem and other violations of quality-control requirements during an inspection of a LifeScan Inc. facility from April through June 2005.
In a letter to the company, the FDA said LifeScan did not properly review and investigate complaints the OneTouch Ultra blood glucose meters may have been providing incorrect measurements.
The company also did not meet requirements for reporting potentially serious injuries that may have been related to the devices within 30 days, the FDA letter said.
“You should take prompt actions to correct these deviations,” the letter said.
A LifeScan spokesman did not immediately respond to a request for comment.
The letter said LifeScan had taken some steps to correct the problems, but other proposed fixes had not been completed.
In April, LifeScan alerted consumers it was possible for users of OneTouch Ultra, InDuo and OneTouch FastTake Meters to accidentally change the unit of measurement and misinterpret results.
The FDA’s letter was dated Dec. 7.
The FDA sends dozens of warning letters each year. Most of the time companies resolve the issues without further penalty.