FDA Inspection
Aqueduct Medical IncorporatedAqueduct Medical Incorporated – FDA Inspection, Dec 7, 2011
Record Details
This FDA Inspection record concerns Aqueduct Medical Incorporated, with an inspection on December 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 7, 2011
- Product Type
- Devices
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ID · 9b4ed16d-d029-4efd-bda8-b30a954c44f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754782
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Aqueduct Medical Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 17, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Aqueduct Medical Incorporated
- FDA Inspection 910593 - 2015-01-23
- FDA Inspection 662474 - 2010-05-17
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