FDA Inspection
Immunodiagnostic Systems LimitedImmunodiagnostic Systems Limited – FDA Inspection, Nov 25, 2010
Record Details
This FDA Inspection record concerns Immunodiagnostic Systems Limited, with an inspection on November 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 25, 2010
- Product Type
- Devices
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ID · b7788e80-03c4-45bf-bc14-d0c19d60434f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 701344
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Immunodiagnostic Systems Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2019 | Not classified | Office of Inspections and Investigations | |
| January 11, 2018 | Not classified | Office of Inspections and Investigations | |
| July 30, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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