Eisai, Inc. FDA Inspection Record
Eisai, Inc. is an FDA-inspected facility (FEI 3009413786) located in Nutley, NJ, US. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 2, 2025: No Action Indicated (NAI)
- Inspections on record
- 7 (3 VAI, 4 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 6, 2009
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 2, 2025 | No Action Indicated (NAI) | No citations listed |
| Feb 9, 2023 | No Action Indicated (NAI) | No citations listed |
| Feb 16, 2018 | Voluntary Action Indicated (VAI) | Ensuring compliance with plan and protocol (21 CFR 312.50) |
| Dec 9, 2015 | Voluntary Action Indicated (VAI) | General responsibilities of sponsors (21 CFR 312.50) |
| Apr 20, 2015 | No Action Indicated (NAI) | No citations listed |
| Jan 17, 2013 | Voluntary Action Indicated (VAI) | Changes to Procedures Not Reviewed, Approved (21 CFR 211.100(a)) Late submission of 15-day report (21 CFR 314.80(c)(1)(i)) |
| Sep 27, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Eisai, Inc.
- Location
- Nutley, NJ (US)
- Source
- inspections