FDA Inspection 760323 — St. Jude Medical
The FDA completed an inspection of St. Jude Medical on November 30, 2011 in Atlanta, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 30, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Atlanta, GA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |