FDA Inspection
Galix Biomedical Instrumentation, Inc.Galix Biomedical Instrumentation, Inc. – FDA Inspection, May 21, 2013
Record Details
This FDA Inspection record concerns Galix Biomedical Instrumentation, Inc., with an inspection on May 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 21, 2013
- Product Type
- Devices
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ID · 76fe32ad-9cd4-4298-aa30-c04d3a5fedf4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 832712
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Galix Biomedical Instrumentation, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 3, 2017 | 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 1016788 - 2017-07-03
- FDA Inspection 615917 - 2009-09-21
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