I-Flow Form 483 Reflects Design, MDR Observations

Kimberly-Clark subsidiary I-Flow landed a 10-observation Form 483 after an inspection by the FDA’s Los Angeles district office. Many of the agency’s concerns focused on the Lake Forest, Calif., plant’s complaint-handling procedures. In at least four instances, no medical device report was filed on reports of infusion pump malfunctions that could have led to death or serious injury.
The GMP Letter