FDA Inspection
Immucor GTI Diagnostics, IncImmucor GTI Diagnostics, Inc – FDA Inspection, Jan 13, 2010
Record Details
This FDA Inspection record concerns Immucor GTI Diagnostics, Inc, with an inspection on January 13, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Immucor GTI Diagnostics, Inc
- Inspection Date
- January 13, 2010
- Product Type
- Devices
View Company Profile
ID · 97a94f54-cdcc-4320-959c-b8645a3f5b01
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 639478
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(d)Acceptance criteria and essential outputs
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Immucor GTI Diagnostics, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Immucor GTI Diagnostics, Inc
- FDA Inspection 977541 - 2016-02-01
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