FDA Inspection
Galix Biomedical Instrumentation, Inc.Galix Biomedical Instrumentation, Inc. – FDA Inspection, Jul 3, 2017
Record Details
This FDA Inspection record concerns Galix Biomedical Instrumentation, Inc., with an inspection on July 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d43d788f-a307-4ce0-aa1c-eb4daa3d37ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016788
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Galix Biomedical Instrumentation, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 21, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Galix Biomedical Instrumentation, Inc.
- FDA Inspection 832712 - 2013-05-21
- FDA Inspection 615917 - 2009-09-21
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