The QMN Weekly Bulletin

I-Flow Form 483 Reflects Design, MDR Observations

Feb. 15, 2013
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.
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