FDA Inspection 911428 — Trillium Technology, Inc.
The FDA completed an inspection of Trillium Technology, Inc. on Jan 30, 2015 in Peoria, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Peoria, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |