FDA Inspection 1146102 — Douglas Terp
The FDA completed an inspection of Douglas Terp on Jun 28, 2021 in Waterville, ME. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 28, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Waterville, ME (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 14513 | 21 CFR 812.2(c)(3) | Needs IDE; diagnostic device exemption conditions not met |
| 2930 | 21 CFR 812.42 | Sponsor began study before IRB/FDA approval |
| 6849 | 21 CFR 812.5(a) | Label does not contain required information |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |