FDA Inspection
Sartorius Stedim Biooutsource LimitedSartorius Stedim Biooutsource Limited – FDA Inspection, Mar 6, 2019
Record Details
This FDA Inspection record concerns Sartorius Stedim Biooutsource Limited, with an inspection on March 6, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b82cb09e-d1ff-4275-a69d-edffe65c8731
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086614
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
Other FDA inspections of Sartorius Stedim Biooutsource Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2025 | Not classified | Office of Inspections and Investigations | |
| December 11, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 26, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sartorius Stedim Biooutsource Limited
- FDA Inspection 1285976 - 2025-09-05
- FDA Inspection 1152873 - 2019-12-11
- FDA Inspection 1029992 - 2017-09-13
- FDA Inspection 956573 - 2016-01-26
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