FDA Inspection
Evoqua Water Technologies LlcEvoqua Water Technologies Llc – FDA Inspection, Apr 9, 2012
Record Details
This FDA Inspection record concerns Evoqua Water Technologies Llc, with an inspection on April 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 9, 2012
- Product Type
- Devices
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ID · 660e3a87-2dd1-4033-b6da-df29d0361a1b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 777228
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of Evoqua Water Technologies Llc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 20, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Evoqua Water Technologies Llc
- FDA Inspection 1018319 - 2017-06-27
- FDA Inspection 820149 - 2013-02-20
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