FDA Inspection 1032311 — Premier Clinical Research LLC
The FDA completed an inspection of Premier Clinical Research LLC on November 29, 2017 in Spokane, WA. 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
- November 29, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Spokane, WA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2944 | 21 CFR 812.43(d) | Monitors not qualified |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |