FDA Inspection 867545 — Evoqua Water Technologies LLC
The FDA completed an inspection of Evoqua Water Technologies LLC on February 18, 2014 in Minneapolis, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 18, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |