Company
GermanyEvonik Operations GmbH, Marl, Germany – FDA Inspections
Inspection records and compliance data for Evonik Operations GmbH in Marl. 4 FDA inspections on record, last inspected June 27, 2024.
Company Profile
This profile covers Evonik Operations GmbH based in Marl, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected February 14, 2012. Last inspected June 27, 2024.
Most cited issue areas
- Calibration - at intervals, written program, remedial action1 inspection
- Computer control of master formula records1 inspection
- Lab controls established, including changes1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 27, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1289284 |
| February 18, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1122166 |
| December 12, 2014 | VAI | Human Drugs · Drug Quality Assurance | 909929 |
| February 14, 2012 | NAI | Human Drugs · Drug Quality Assurance | 772140 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Evonik Operations GmbH
FEI Number
3002911044
Address
Paul-Baumann-Str. 1, Marl, Germany
Country
Germany
ID: e2b1ddde-f817-4199-afcc-3aeed833f429