FDA 483 - SurGenTec, LLC - April 18, 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.
Surgentec, LLC, a medical device manufacturer in Boca Raton, FL, was inspected by the FDA, revealing significant deficiencies. The inspection identified inadequate procedures for design validation, particularly concerning packaging changes for the Graftgun Universal Graft Delivery System. Additionally, the firm's Medical Device Reporting (MDR) procedures lacked proper documentation and recordkeeping, and corrective and preventive action (CAPA) processes were not adequately established or fully implemented.
ID · c008e4c5-e8bd-4515-9db2-c9e97d753984