Company
GermanyRentschler Biopharma SE, Baden-Wurttemberg, Germany – FDA Inspections
Inspection records and compliance data for Rentschler Biopharma SE in Baden-Wurttemberg. 10 FDA inspections on record, 3 Form 483s, last inspected May 05, 2023.
Company Profile
This profile covers Rentschler Biopharma SE based in Baden-Wurttemberg, Germany.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 6
- NAI
- 1
- Unclassified
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected July 19, 2011. Last inspected May 5, 2023.
Most cited issue areas
- Equipment Design, Size and Location1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 5, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1246782 |
| March 7, 2023 | Not classified | Human Drugs | 1202157 |
| February 26, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1160831 |
| August 9, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1102650 |
| March 8, 2018 | Not classified | Human Drugs | 1046488 |
| May 23, 2017 | Not classified | Human Drugs | 1022082 |
| December 6, 2016 | VAI | Human Drugs · Drug Quality Assurance | 999800 |
| June 16, 2015 | VAI | Human Drugs · Drug Quality Assurance | 933400 |
| September 20, 2013 | VAI | Human Drugs · Drug Quality Assurance | 853179 |
| July 19, 2011 | VAI | Human Drugs · Drug Quality Assurance | 744719 |
FDA documents
EIRs (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Rentschler Biopharma SE
FEI Number
1000291122
Address
Erwin-Rentschler-Str. 21 Laupheim, Baden-Wurttemberg, Germany
Country
Germany
ID: da50fa41-24f6-449f-bf90-45eccb97d9ba