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Medical Devices / Inspections and Audits

FDA Flags LZRY7’s MDR Procedures

Dec. 11, 2017

LZR7 in Placerville, California, drew a Form 483 following an October inspection, observing its MDR procedures failed to not address numerous issues.

The procedures did not establish a standardized review process for determining when an event should be reported, and did not allow the timely transmission of complete medical device reports to the FDA.

The procedures also did not establish internal systems that would allow efficient and effective analysis of events that might be subject to MDR requirements, the agency said.

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