FDA Inspection
Ingenus Pharmaceuticals GmbHIngenus Pharmaceuticals GmbH – FDA Inspection, Dec 11, 2018
Record Details
This FDA Inspection record concerns Ingenus Pharmaceuticals GmbH, with an inspection on December 11, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 77f0d2b8-0f1b-47cc-a2e6-7b9415943972
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074093
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.130(e)Packaging line inspection documentation
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Ingenus Pharmaceuticals GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2024 | Not classified | Office of Inspections and Investigations | |
| December 3, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 31, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ingenus Pharmaceuticals GmbH
- FDA Inspection 1263921 - 2024-10-03
- FDA Inspection 1115845 - 2019-12-03
- FDA Inspection 1034770 - 2017-10-31
- FDA Inspection 905257 - 2014-11-04
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