FDA Inspection
Synergy Orthopaedic Systems, IncSynergy Orthopaedic Systems, Inc – FDA Inspection, Aug 13, 2012
Record Details
This FDA Inspection record concerns Synergy Orthopaedic Systems, Inc, with an inspection on August 13, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 13, 2012
- Product Type
- Biologics
View Company Profile
ID · 13e48c3f-ed33-43b0-a4fe-218bd63fcd53
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 795527
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.195(b)Corrective actions
- 21 CFR 1271.265(c)(1)Release of HCT/Ps by responsible person
- 21 CFR 1271.170(b)Not qualified, authorized for functions
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.180(b)Review and approval-responsible person
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synergy Orthopaedic Systems, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Synergy Orthopaedic Systems, Inc
- FDA Inspection 637253 - 2010-01-11
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.