FDA Inspection
Sentiss Pharma Private Ltd.Sentiss Pharma Private Ltd. – FDA Inspection, May 14, 2019
Record Details
This FDA Inspection record concerns Sentiss Pharma Private Ltd., with an inspection on May 14, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8b9ba13c-21c3-43ae-8796-7b3b825eb224
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1092166
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.165(c)Sampling and testing plans not followed
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Other FDA inspections of Sentiss Pharma Private Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2017 | 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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