FDA Inspection
Mediware Chicago Service CenterMediware Chicago Service Center – FDA Inspection, Aug 9, 2011
Record Details
This FDA Inspection record concerns Mediware Chicago Service Center, with an inspection on August 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 9, 2011
- Product Type
- Devices
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ID · 4866a8ed-2ef5-417b-bf49-3685d4720f91
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 739974
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Mediware Chicago Service Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mediware Chicago Service Center
- FDA Inspection 932474 - 2015-06-18
- FDA Inspection 658474 - 2010-04-13
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