FDA Inspection
Svizera Labs Private LtdSvizera Labs Private Ltd – FDA Inspection, Jul 21, 2016
Record Details
This FDA Inspection record concerns Svizera Labs Private Ltd, with an inspection on July 21, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Svizera Labs Private Ltd
- Inspection Date
- July 21, 2016
- Product Type
- Drugs
View Company Profile
ID · 3162fccd-8059-45cb-8b7b-530bdb5c150a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982630
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Svizera Labs Private Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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