FDA Inspection
Argentum Medical, LlcArgentum Medical, Llc – FDA Inspection, Mar 19, 2018
Record Details
This FDA Inspection record concerns Argentum Medical, Llc, with an inspection on March 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 97d9ee02-3cb8-492c-aa8e-0e7aa2278d6e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1044796
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Argentum Medical, Llc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 9, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 18, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Argentum Medical, Llc
- FDA Inspection 1073627 - 2018-11-06
- FDA Inspection 907398 - 2014-12-12
- FDA Inspection 813653 - 2013-01-09
- FDA Inspection 720259 - 2011-04-18
- FDA Inspection 667226 - 2010-05-20
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