FDA Inspection
GlobalMed Inc.GlobalMed Inc. – FDA Inspection, Sep 6, 2013
Record Details
This FDA Inspection record concerns GlobalMed Inc., with an inspection on September 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GlobalMed Inc.
- Inspection Date
- September 6, 2013
- Product Type
- Devices
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ID · f665bf97-7a2a-40b8-a4e5-18d8f853d24a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 847862
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of GlobalMed Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 7, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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