Company
United StatesShionogi Inc., Florham Park, NJ – FDA Inspections
Inspection records and compliance data for Shionogi Inc. in Florham Park, New Jersey. 7 FDA inspections on record, last inspected February 13, 2026.
Company Profile
This profile covers Shionogi Inc. based in Florham Park, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 29, 2011. Last inspected February 13, 2026.
Most cited issue areas
- Records of receipt, shipment, disposition1 inspection
- Transfer of obligations1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2026 | Not classified | Human Drugs | 1305578 |
| December 19, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1115062 |
| March 12, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1047601 |
| October 7, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 992012 |
| November 17, 2015 | NAI | Human Drugs · Bioresearch Monitoring | 948537 |
| November 5, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 807882 |
| September 29, 2011 | NAI | Human Drugs · Bioresearch Monitoring | 748084 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Shionogi Inc.
FEI Number
3008581870
Address
300 Campus Dr Ste 300, Florham Park, New Jersey 07932, United States
Country
United States
ID: 1ee5c238-9c75-4bdd-97e2-379adba1ce0e