Company
United StatesIpsen Bioscience, Inc., Cambridge, MA – FDA Inspections
Inspection records and compliance data for Ipsen Bioscience, Inc. in Cambridge, Massachusetts. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected May 20, 2025.
Company Profile
This profile covers Ipsen Bioscience, Inc. based in Cambridge, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected July 17, 2015. Last inspected May 20, 2025.
Most cited issue areas
- Annual visual exams of drug products1 inspection
- Certificates of Testing (Containers, Closures)1 inspection
- Contamination, chemical or physical change, deterioration1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 20, 2025 | Not classified | Human Drugs | 1270829 |
| February 26, 2019 | Not classified | Human Drugs · Drug Quality Assurance | 1080531 |
| December 5, 2017 | OAI | Human Drugs · Generic Drug Evaluation | 1034205 |
| July 17, 2015 | VAI | Human Drugs · Drug Quality Assurance | 940914 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ipsen Bioscience, Inc.
FEI Number
3008532848
Address
1 Kendall Sq Bldg 700 Ste 7401, Cambridge, Massachusetts 02139, United States
Country
United States
ID: 657abb7a-6718-44e6-b6d5-aa7f903387d8