Devicemaker Gets Warning for Lack of Quality Policies, Training

FDA investigators found fault with Canada-based Intelligent Hospital Systems’ (HIS) failure to establish a plan defining quality practices, resources and activities relevant to its devices and its failure to spell out how quality requirements will be met, according to a recent warning letter.

Further, IHS had no quality plan or procedure describing all of the quality system activities and their relationships to the design and manufacturing of its Robotic IV Automation device, according to the warning letter.

Unfortunately, because IHS didn’t move fast enough with three of its four Form 483 responses, the agency reviewed only the first response to the citations. It may consider the other three along with IHS’ response to the warning letter, FDA said.

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