FDA Inspection
Sartorius Stedim North America, Inc.Sartorius Stedim North America, Inc. – FDA Inspection, Jun 23, 2023
Record Details
This FDA Inspection record concerns Sartorius Stedim North America, Inc., with an inspection on June 23, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ae30ec2d-a867-4b83-8c0a-4d110d27b1e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208719
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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