FDA Inspection
Aqueduct Medical IncorporatedAqueduct Medical Incorporated – FDA Inspection, May 17, 2010
Record Details
This FDA Inspection record concerns Aqueduct Medical Incorporated, with an inspection on May 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 17, 2010
- Product Type
- Devices
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ID · cbfb9164-f783-449c-8825-bb5c70b6aeb4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 662474
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
18- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Showing 10 of 18 citations.
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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 |
| December 7, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Aqueduct Medical Incorporated
- FDA Inspection 910593 - 2015-01-23
- FDA Inspection 754782 - 2011-12-07
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