FDA Inspection
St. Jude MedicalSt. Jude Medical – FDA Inspection, Jan 22, 2010
Record Details
This FDA Inspection record concerns St. Jude Medical, with an inspection on January 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- St. Jude Medical
- Inspection Date
- January 22, 2010
- Product Type
- Devices
View Company Profile
ID · 472cadb4-f2f6-40e7-a063-24b67f3d43ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 646942
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(b)(2)Resources
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)(5)Implementing changes
- 21 CFR 820.100(a)(6)Dissemination of problem information
Full citation text and observation details available on the Dashboard.
Other FDA inspections of St. Jude Medical
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 11, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 28, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for St. Jude Medical
- FDA Inspection 1089439 - 2019-03-20
- FDA Inspection 967750 - 2016-04-11
- FDA Inspection 903706 - 2014-07-31
- FDA Inspection 771571 - 2012-02-28
- FDA Inspection 721939 - 2011-04-21
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