FDA Inspection 820149 — Evoqua Water Technologies Llc
The FDA completed an inspection of Evoqua Water Technologies Llc on February 20, 2013 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |