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Medical Devices / Inspections and Audits

Lusys Laboratories Slammed for Host of Violations in 483

Sept. 18, 2019

A 16-item Form 483 highlighted a litany of QMS lapses uncovered at Lusys Laboratories’ San Diego, California plant during a Jan. 22-Feb. 7 FDA inspection.

The agency investigator found inadequate risk analysis, design controls and acceptance activities, failure to maintain a device master record, and failure to establish procedures for corrective and preventive actions.

Design control procedures didn’t provide instructions on how to perform and document design validation activities, and the risk analysis was inadequate, the investigator said.

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