FDA Inspection
Global Medical Holdings LLCGlobal Medical Holdings LLC – FDA Inspection, Sep 6, 2012
Record Details
This FDA Inspection record concerns Global Medical Holdings LLC, with an inspection on September 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Global Medical Holdings LLC
- Inspection Date
- September 6, 2012
- Product Type
- Devices
View Company Profile
ID · a58f9f90-507d-47c3-a316-3f6b489354de
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 798377
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.198(b)Review and evaluation for investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Global Medical Holdings LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Global Medical Holdings LLC
- FDA Inspection 871223 - 2014-04-11
- FDA Inspection 841967 - 2013-07-19
- FDA Inspection 591682 - 2009-06-24
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