FDA Inspection
St Jude Medical IncSt Jude Medical Inc – FDA Inspection, Mar 25, 2010
Record Details
This FDA Inspection record concerns St Jude Medical Inc, with an inspection on March 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- St Jude Medical Inc
- Inspection Date
- March 25, 2010
- Product Type
- Devices
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ID · e1ffd154-252e-47e9-a49e-4de12e36366e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 651144
- 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 820.198(e)(5)Nature and details of complaint
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of St Jude Medical Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 3, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 21, 2010 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for St Jude Medical Inc
- FDA Inspection 878348 - 2014-05-06
- FDA Inspection 801786 - 2012-10-03
- FDA Inspection 681486 - 2010-09-21
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