Company
SwitzerlandIngenus Pharmaceuticals GmbH, Barbengo, Switzerland – FDA Inspections
Inspection records and compliance data for Ingenus Pharmaceuticals GmbH in Barbengo. 5 FDA inspections on record, 2 Form 483s, last inspected October 03, 2024.
Company Profile
This profile covers Ingenus Pharmaceuticals GmbH based in Barbengo, Switzerland.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 4, 2014. Last inspected October 3, 2024.
Most cited issue areas
- Authority lacking to review records, investigate errors1 inspection
- Batch production and Batch Control Record Requirements1 inspection
- Control procedures to monitor and validate performance1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 3, 2024 | Not classified | Human Drugs | 1263921 |
| December 3, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1115845 |
| December 11, 2018 | VAI | Human Drugs · Generic Drug Evaluation | 1074093 |
| October 31, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1034770 |
| November 4, 2014 | VAI | Human Drugs · Drug Quality Assurance | 905257 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ingenus Pharmaceuticals GmbH
FEI Number
3005403232
Address
Via Cadepiano 24, Barbengo, Switzerland
Country
Switzerland
ID: 2255ec6f-3349-4a71-be33-91a83420b530