Company
GermanyOncotec Pharma Produktion GmbH, Dessau Rosslau, Germany – FDA Inspections
Inspection records and compliance data for Oncotec Pharma Produktion GmbH in Dessau Rosslau. 6 FDA inspections on record, 1 Form 483, last inspected October 17, 2024.
Company Profile
This profile covers Oncotec Pharma Produktion GmbH based in Dessau Rosslau, Germany.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 4, 2012. Last inspected October 17, 2024.
Most cited issue areas
- Procedures for sterile drug products1 inspection
- Training , Education , Experience overall1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 17, 2024 | Not classified | Human Drugs | 1308746 |
| September 3, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1172380 |
| September 27, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1107455 |
| November 7, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1030852 |
| April 17, 2014 | NAI | Human Drugs · Drug Quality Assurance | 878575 |
| October 4, 2012 | NAI | Human Drugs · Drug Quality Assurance | 803872 |
FDA documents
EIRs (1)
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Company Information
Name
Oncotec Pharma Produktion GmbH
FEI Number
3009238374
Address
Am Pharmapark, Dessau Rosslau, Germany
Country
Germany
ID: 7789d312-a14f-4f62-93df-246fa5e3d350