Exact Sciences Corporation- Innovation Campus — FDA Facility Profile
Exact Sciences Corporation- Innovation Campus is an FDA-registered facility (FEI 3008256118) located in Madison, WI, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 22, 2023: No Action Indicated (NAI)
- Inspections on record
- 5 (5 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Apr 28, 2017
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 22, 2023 | No Action Indicated (NAI) | No citations listed |
| Aug 1, 2019 | No Action Indicated (NAI) | No citations listed |
| Nov 5, 2015 | No Action Indicated (NAI) | No citations listed |
| Jul 11, 2014 | No Action Indicated (NAI) | No citations listed |
| Oct 25, 2013 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Apr 28, 2017 | Not yet classified | Z-2219-2017 | Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use.
The Exact Sciences Sample… Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the… |
Facility details
- Company
- Exact Sciences Corporation
- Location
- Madison, WI (US)
- Source
- device