FDA Inspection
Oncotec Pharma Produktion GmbHOncotec Pharma Produktion GmbH – FDA Inspection, Nov 7, 2017
Record Details
This FDA Inspection record concerns Oncotec Pharma Produktion GmbH, with an inspection on November 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · ff562387-a854-44b4-9a73-abcc10c454c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030852
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.113(b)Procedures for sterile drug products
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oncotec Pharma Produktion GmbH
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2024 | Not classified | Office of Inspections and Investigations | |
| September 3, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 17, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 4, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Oncotec Pharma Produktion GmbH
- FDA Inspection 1308746 - 2024-10-17
- FDA Inspection 1172380 - 2021-09-03
- FDA Inspection 1107455 - 2019-09-27
- FDA Inspection 878575 - 2014-04-17
- FDA Inspection 803872 - 2012-10-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.