FDA Inspection
Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.)Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) – FDA Inspection, Apr 24, 2019
Record Details
This FDA Inspection record concerns Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.), with an inspection on April 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 24, 2019
- Product Type
- Devices
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ID · 222f0094-df3b-4958-a19a-f90e199695d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087290
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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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 | |
| October 18, 2016 | 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 991765 - 2016-10-18
- FDA Inspection 933831 - 2015-06-17
- FDA Inspection 816055 - 2013-02-19
- FDA Inspection 740649 - 2011-08-23
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