FDA Issues 483 to Devicemaker for MDR Procedures, Complaint Evaluations

July 31, 2019

Shoreline, Washington device manufacturer US Biotek Laboratories was hit with a Form 483 for a lack of complaint evaluations and the absence of medical device reporting (MDR) procedures.

Following its November 13-14, 2018 inspection, the investigator wrote the blood and urine collection kit maker up for not having MDR procedures that documented manufacturer reporting requirements.

Additionally, the laboratory manager told the investigator the firm had no procedure requiring the evaluation of all device complaints in order to figure out if the related event should be reported to the FDA.

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