FDA Inspection
MedtronicMedtronic – FDA Inspection, Jan 22, 2010
Record Details
This FDA Inspection record concerns Medtronic, with an inspection on January 22, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Medtronic
- Inspection Date
- January 22, 2010
- Product Type
- Biologics
View Company Profile
ID · 9165a407-dcef-4399-8684-fe7843019ac5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 642881
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.180(c)Availability of procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 5, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 24, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Medtronic
- FDA Inspection 961416 - 2016-02-01
- FDA Inspection 864805 - 2014-02-05
- FDA Inspection 769018 - 2012-02-24
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.