FDA Inspection 711749 — Trinity Enterprise Inc
The FDA completed an inspection of Trinity Enterprise Inc on Feb 18, 2011 in Mt Prospect, 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
- Feb 18, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mt Prospect, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |