FDA Inspection
Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.)Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) – FDA Inspection, Oct 18, 2016
Record Details
This FDA Inspection record concerns Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.), with an inspection on October 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 18, 2016
- Product Type
- Devices
- Person
- Marissa S. Steinhagen (Issuing Officer)
View Company Profile
ID · 6bbb807f-a029-4e11-b55b-a96e7b4a64a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991765
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Design history file
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 |
| June 17, 2015 | 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 933831 - 2015-06-17
- FDA Inspection 816055 - 2013-02-19
- FDA Inspection 740649 - 2011-08-23
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.