FDA Inspection
Pinnacle Spine Group, LLCPinnacle Spine Group, LLC – FDA Inspection, Mar 13, 2013
Record Details
This FDA Inspection record concerns Pinnacle Spine Group, LLC, with an inspection on March 13, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Pinnacle Spine Group, LLC
- Inspection Date
- March 13, 2013
- Product Type
- Biologics
View Company Profile
ID · fb62424c-c641-4e27-8942-d153acda7c90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 822071
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 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.