FDA Inspection
Sun Pharmaceutical Industries LimitedSun Pharmaceutical Industries Limited – FDA Inspection, Aug 12, 2022
Record Details
This FDA Inspection record concerns Sun Pharmaceutical Industries Limited, with an inspection on August 12, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 12, 2022
- Product Type
- Drugs
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ID · 88a2745c-b214-453b-b024-def59e8e55f4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1177459
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Sun Pharmaceutical Industries Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 12, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sun Pharmaceutical Industries Limited
- FDA Inspection 1117962 - 2020-02-07
- FDA Inspection 1094000 - 2019-05-10
- FDA Inspection 1068079 - 2018-09-14
- FDA Inspection 994372 - 2016-11-16
- FDA Inspection 812385 - 2012-12-12
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