FDA Inspection
Sentiss Pharma Private Ltd.Sentiss Pharma Private Ltd. – FDA Inspection, May 23, 2017
Record Details
This FDA Inspection record concerns Sentiss Pharma Private Ltd., with an inspection on May 23, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9a480224-6794-453a-9fb8-6d28ba62c6de
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1015447
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Sentiss Pharma Private Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 3, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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