FDA Inspection
IO Orthopedic Systems LLCIO Orthopedic Systems LLC – FDA Inspection, Jun 1, 2017
Record Details
This FDA Inspection record concerns IO Orthopedic Systems LLC, with an inspection on June 1, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · 0df24f47-9e27-4dc4-9343-1ef605590ba0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012343
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.265(a)Evaluation--microorganisms, damage
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
Full citation text and observation details available on the Dashboard.
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.