FDA Inspection
Sentiss Pharma Private Ltd.Sentiss Pharma Private Ltd. – FDA Inspection, Jul 29, 2014
Record Details
This FDA Inspection record concerns Sentiss Pharma Private Ltd., with an inspection on July 29, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sentiss Pharma Private Ltd.
- Inspection Date
- July 29, 2014
- Product Type
- Drugs
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ID · b9d7e39b-1a70-47fa-8bd9-4a73d062f258
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 890528
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| May 23, 2017 | 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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