483
OrthoFundamentals, LlcOrthoFundamentals, Llc – FDA 483, May 20, 2025
Record Details
An FDA inspection of OrthoFundamentals, Llc identified significant deficiencies across multiple quality system areas. The firm failed to adequately establish procedures for design control, complaint handling, corrective and preventive actions, risk analysis, and supplier management. These issues led to inadequately validated design changes for their Trellis SI Joint Fusion System, insufficient investigation of complaints, and a lack of robust processes for identifying and mitigating risks.
- Person
View Company Profile
ID · 3eb5342f-5851-46f3-84a5-5ef718fa4922
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.