FDA Inspection 1054701 — Ingeneron, Inc
The FDA completed an inspection of Ingeneron, Inc on Jun 6, 2018 in Houston, TX. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 6, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3696 | 21 CFR 820.100(b) | Documentation |