Company
GermanyCatalent Germany Schorndorf GmbH, Schorndorf, Germany – FDA Inspections
Inspection records and compliance data for Catalent Germany Schorndorf GmbH in Schorndorf. 7 FDA inspections on record, 2 Form 483s, last inspected March 17, 2022.
Company Profile
This profile covers Catalent Germany Schorndorf GmbH based in Schorndorf, Germany.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 5
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected September 3, 2009. Last inspected March 17, 2022.
Most cited issue areas
- Complete test data included in records1 inspection
- In-Process and Laboratory Control Results1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1205903 |
| February 14, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1127864 |
| September 21, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1066669 |
| October 26, 2016 | VAI | Human Drugs · New Drug Evaluation | 996275 |
| February 7, 2014 | NAI | Human Drugs · Drug Quality Assurance | 868435 |
| February 10, 2012 | NAI | Human Drugs · Drug Quality Assurance | 772774 |
| September 3, 2009 | VAI | Human Drugs · Drug Quality Assurance | 620300 |
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
Catalent Germany Schorndorf GmbH
FEI Number
3003831171
Address
Steinbeisstr. 2, Schorndorf, Germany
Country
Germany
ID: 5ca247a6-5177-40c5-a0b8-2ef0d4d0d31b