FDA Inspection
GlobalMed Inc.GlobalMed Inc. – FDA Inspection, Apr 27, 2023
Record Details
This FDA Inspection record concerns GlobalMed Inc., with an inspection on April 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a921c5ec-c16d-4d34-8f2a-aa62ddad09b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206090
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of GlobalMed Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| September 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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