FDA Inspection
Svizera Labs Private LtdSvizera Labs Private Ltd – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns Svizera Labs Private Ltd, with an inspection on August 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9ba87aa8-c776-4230-bfdf-50532b3b771b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063838
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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Other FDA inspections of Svizera Labs Private Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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