FDA Inspection
Evoqua Water Technologies LLCEvoqua Water Technologies LLC – FDA Inspection, Dec 13, 2018
Record Details
This FDA Inspection record concerns Evoqua Water Technologies LLC, with an inspection on December 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 44ac4e6f-e481-4fc6-b6be-ddc08055f5aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074301
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Evoqua Water Technologies LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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