FDA Inspection 696529 — American Association of Acupuncture and Bio-Energetic Medici
The FDA completed an inspection of American Association of Acupuncture and Bio-Energetic Medici on November 5, 2010 in Kapolei, HI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 5, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Kapolei, HI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7309 | 21 CFR 56.111(a)(1) | Risks minimized by sound research design |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7652 | 21 CFR 56.113 | Reporting |