FDA Inspection
Monarch Medical Technologies, LLCMonarch Medical Technologies, LLC – FDA Inspection, Feb 19, 2019
Record Details
This FDA Inspection record concerns Monarch Medical Technologies, LLC, with an inspection on February 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 85a43ed9-6d8e-4afc-972f-633b5295649e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079816
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Monarch Medical Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Monarch Medical Technologies, LLC
- FDA Inspection 1241052 - 2024-05-10
- FDA Inspection 953450 - 2015-12-10
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