FDA Inspection
Evoqua Water Technologies LLCEvoqua Water Technologies LLC – FDA Inspection, Jun 25, 2018
Record Details
This FDA Inspection record concerns Evoqua Water Technologies LLC, with an inspection on June 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 72bb0dc5-d86f-4572-abc8-6c4e0d445a7c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1056819
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Evoqua Water Technologies LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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