FDA Inspection 818897 — American Association of Acupuncture and Bio-Energetic Medici
The FDA completed an inspection of American Association of Acupuncture and Bio-Energetic Medici on February 8, 2013 in Kapolei, HI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 8, 2013
- Fiscal Year
- 2013
- 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 |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |