FDA Inspection
Rentschler Biopharma SERentschler Biopharma SE – FDA Inspection, Dec 6, 2016
Record Details
This FDA Inspection record concerns Rentschler Biopharma SE, with an inspection on December 6, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fd3c2655-b57f-4166-9399-c3a17930da99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 999800
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Rentschler Biopharma SE
9| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 7, 2023 | Not classified | Office of Inspections and Investigations | |
| February 26, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Rentschler Biopharma SE
- FDA Inspection 1246782 - 2023-05-05
- FDA Inspection 1202157 - 2023-03-07
- FDA Inspection 1160831 - 2021-02-26
- FDA Inspection 1102650 - 2019-08-09
- FDA Inspection 1046488 - 2018-03-08
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