FDA Inspection
MARVAO MEDICAL DEVICES LTD.MARVAO MEDICAL DEVICES LTD. – FDA Inspection, Jan 29, 2020
Record Details
This FDA Inspection record concerns MARVAO MEDICAL DEVICES LTD., with an inspection on January 29, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MARVAO MEDICAL DEVICES LTD.
- Inspection Date
- January 29, 2020
- Product Type
- Devices
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ID · f8dd174c-7545-4ee4-bcb2-75149ffa6411
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1119024
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of MARVAO MEDICAL DEVICES LTD.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 13, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for MARVAO MEDICAL DEVICES LTD.
- FDA Inspection 888775 - 2014-07-17
- FDA Inspection 827734 - 2013-03-13
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