FDA Inspection
Resuscitation International LLCResuscitation International LLC – FDA Inspection, Apr 11, 2017
Record Details
This FDA Inspection record concerns Resuscitation International LLC, with an inspection on April 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b7052492-561e-4594-a543-9edb6792e825
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1010399
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Resuscitation International LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Resuscitation International LLC
- FDA Inspection 821192 - 2013-01-24
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