483
Prescient Surgical, Inc.FDA 483 - Prescient Surgical, Inc. - July 19, 2019
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
Prescient Surgical, Inc. in San Carlos, CA, a medical device manufacturer, was cited with three observations during an FDA inspection. The inspection revealed deficiencies in process validation, design control procedures, and documentation of acceptance activities, indicating a need for improved quality system controls.
Open in Dashboard
ID · f7304a6c-7791-4726-90b4-8ff52c980011