FDA Inspection 947370 — Oeyama-Moto-Medical Group Foundation, LLC
The FDA completed an inspection of Oeyama-Moto-Medical Group Foundation, LLC on September 29, 2015 in West Covina, CA. 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 29, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- West Covina, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7639 | 21 CFR 312.20(b) | Starting a study before IND is in effect |