FDA Inspection
DePuy Spine, Inc.DePuy Spine, Inc. – FDA Inspection, Mar 11, 2009
Record Details
This FDA Inspection record concerns DePuy Spine, Inc., with an inspection on March 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DePuy Spine, Inc.
- Inspection Date
- March 11, 2009
- Product Type
- Devices
View Company Profile
ID · fbae0f00-6351-4381-8880-c738dccef97c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 569059
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
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Other FDA inspections of DePuy Spine, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 16, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 28, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DePuy Spine, Inc.
- FDA Inspection 1090256 - 2019-04-18
- FDA Inspection 1021012 - 2017-06-16
- FDA Inspection 787390 - 2012-06-11
- FDA Inspection 767079 - 2012-02-10
- FDA Inspection 580522 - 2009-04-28
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