FDA Inspection 1109049 — TriReme Medical, LLC.
The FDA completed an inspection of TriReme Medical, LLC. on October 30, 2019 in Pleasanton, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 30, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Pleasanton, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |