FDA Inspection 678981 — John Caton Jr
The FDA completed an inspection of John Caton Jr on August 20, 2010 in Springfield, OR. 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 20, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Springfield, OR (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7543 | 21 CFR 312.61 | Unauthorized recipients (investigator) |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |