FDA Inspection
INTERVASCULAR, SASINTERVASCULAR, SAS – FDA Inspection, Sep 19, 2019
Record Details
This FDA Inspection record concerns INTERVASCULAR, SAS, with an inspection on September 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b367dd8d-0a04-4e6d-873e-153f35553cc5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102286
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of INTERVASCULAR, SAS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for INTERVASCULAR, SAS
- FDA Inspection 931561 - 2015-06-18
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