483
CrossRoads Extremity Systems, LLCFDA 483 - CrossRoads Extremity Systems, LLC - August 02, 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
CrossRoads Extremity Systems, LLC in Memphis, TN, was inspected by the FDA, resulting in four observations. The inspection revealed deficiencies in documenting justifications for not reporting field corrective actions and inadequate complaint handling for MDR reportable events. Additionally, the firm failed to adequately establish complaint procedures and maintain its device master record.
Open in Dashboard
ID · 274752c9-cd30-4272-9b83-6abdf47044cf