FDA Inspection
Microvention, Inc.Microvention, Inc. – FDA Inspection, Jan 28, 2015
Record Details
This FDA Inspection record concerns Microvention, Inc., with an inspection on January 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Microvention, Inc.
- Inspection Date
- January 28, 2015
- Product Type
- Devices
View Company Profile
ID · c13f7fad-5f17-4546-8b2a-7b935817a6f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 915040
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Microvention, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2025 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 24, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 25, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 30, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Microvention, Inc.
- FDA Inspection 1258987 - 2025-01-08
- FDA Inspection 1153926 - 2021-05-24
- FDA Inspection 986764 - 2016-08-25
- FDA Inspection 830029 - 2013-04-30
- FDA Inspection 629675 - 2009-11-20
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