Company
GermanyAesica Pharmaceutical GmbH, Monheim am Rhein, Germany – FDA Inspections
Inspection records and compliance data for Aesica Pharmaceutical GmbH in Monheim am Rhein. 5 FDA inspections on record, last inspected September 12, 2024.
Company Profile
This profile covers Aesica Pharmaceutical GmbH based in Monheim am Rhein, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected November 11, 2011. Last inspected September 12, 2024.
Most cited issue areas
- Calibration - at intervals, written program, remedial action1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 12, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1306304 |
| July 1, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1190265 |
| September 20, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1032046 |
| January 17, 2014 | NAI | Human Drugs · Drug Quality Assurance | 866229 |
| November 11, 2011 | VAI | Human Drugs · Drug Quality Assurance | 759369 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Aesica Pharmaceutical GmbH
FEI Number
3002943189
Address
Alfred-Nobel-Str. 10, Monheim am Rhein, Germany
Country
Germany
ID: f804258b-606a-4c98-a131-7d238212ef12