FDA Inspection
Zenara Pharma Pvt LtdZenara Pharma Pvt Ltd – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns Zenara Pharma Pvt Ltd, with an inspection on April 26, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 2ddc5408-9e05-46cb-9af7-3515fb06f7c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088857
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Zenara Pharma Pvt Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2023 | Not classified | Office of Inspections and Investigations |
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