FDA Inspection
MICROVENTION INC.MICROVENTION INC. – FDA Inspection, May 4, 2023
Record Details
This FDA Inspection record concerns MICROVENTION INC., with an inspection on May 4, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a5d5a852-a6a1-4e5d-b32d-19f7d0a08888
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205080
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(g)Design validation - user needs and intended uses
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MICROVENTION INC.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 17, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 29, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 13, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MICROVENTION INC.
- FDA Inspection 1155400 - 2021-06-22
- FDA Inspection 1077480 - 2019-01-17
- FDA Inspection 1074141 - 2018-11-29
- FDA Inspection 943775 - 2015-09-25
- FDA Inspection 757144 - 2011-12-13
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