FDA 483 - Lacrimedics Inc - January 23, 2020

LacriMedics Inc, a manufacturer of punctum plugs and VisiPlug medical devices in DuPont, WA, was cited for multiple procedural deficiencies during an FDA inspection. Observations included inadequate corrective and preventive action procedures, lack of environmental control procedures for temperature monitoring, undocumented critical supplier evaluations, and insufficient document control requiring signatures on quality system records. These issues indicate a general weakness in the firm's quality management system.