483
Pyrexar Medical, Inc.FDA 483 - Pyrexar Medical, Inc. - May 18, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
An FDA inspection of Pyrexar Medical, Inc. in West Valley City, UT, from May 9-18, 2022, revealed a significant quality system deficiency regarding complaint handling. The firm failed to properly investigate customer complaints or document justifications for not investigating them, as required by their procedures. This indicates a breakdown in their complaint management process for medical devices.
Open in Dashboard
ID · dd79640f-f64b-427c-a8de-70ecf1a579a8