FDA Inspection
Immunodiagnostic Systems LimitedImmunodiagnostic Systems Limited – FDA Inspection, Jul 30, 2015
Record Details
This FDA Inspection record concerns Immunodiagnostic Systems Limited, with an inspection on July 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 30, 2015
- Product Type
- Devices
View Company Profile
ID · c972b53f-e9d3-433c-99d6-888b736928ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938975
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
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 | |
| November 25, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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