FDA Inspection
Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.)Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) – FDA Inspection, Jun 17, 2015
Record Details
This FDA Inspection record concerns Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.), with an inspection on June 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 17, 2015
- Product Type
- Devices
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ID · d5ba38bd-c41d-49c6-9678-6839ee823e7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 933831
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.)
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2026 | Not classified | Minneapolis District Office | |
| April 24, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 18, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 19, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 23, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.)
- FDA Inspection 1339918 - 2026-09-30
- FDA Inspection 1087290 - 2019-04-24
- FDA Inspection 991765 - 2016-10-18
- FDA Inspection 816055 - 2013-02-19
- FDA Inspection 740649 - 2011-08-23
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