FDA Inspection
St. Jude MedicalSt. Jude Medical – FDA Inspection, Nov 30, 2011
Record Details
This FDA Inspection record concerns St. Jude Medical, with an inspection on November 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- St. Jude Medical
- Inspection Date
- November 30, 2011
- Product Type
- Devices
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ID · 25250cb1-f9c6-43d4-845e-b854b7f13c47
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 760323
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
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Other FDA inspections of St. Jude Medical
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 20, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 26, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 15, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for St. Jude Medical
- FDA Inspection 1241032 - 2024-08-13
- FDA Inspection 1049574 - 2018-03-20
- FDA Inspection 980509 - 2016-07-28
- FDA Inspection 932468 - 2015-06-26
- FDA Inspection 736134 - 2011-06-15
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