483
McGinley Orthopaedic Innovations LLCMcGinley Orthopaedic Innovations LLC – FDA 483, Jun 5, 2025
Record Details
McGinley Orthopaedic Innovations LLC in Casper, WY, was inspected by the FDA from June 3-5, 2025. The inspection revealed that the firm's procedures for ensuring equipment is routinely calibrated and checked were not adequately established. This included having five tools with expired calibrations in service and failing to follow its own procedure for a passivation process by lacking necessary controls and a known solution.
- Office
- Denver District Office
- Person
View Company Profile
ID · f76e1efd-a7b3-4bee-823a-1c61f0a9d946
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.