FDA Inspection
Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. – FDA Inspection, Jul 22, 2010
Record Details
This FDA Inspection record concerns Sun Pharmaceutical Industries, Inc., with an inspection on July 22, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 22, 2010
- Product Type
- Drugs
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ID · 1ee2eb8a-64a3-4427-9da0-d8906f79f5eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671670
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
- 21 CFR 211.82(a)Examination on receipt, before acceptance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 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)Defined areas of adequate size for operations
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Sun Pharmaceutical Industries, Inc.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2025 | VAI | New England District Office | Drug Quality Assurance |
| December 23, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 19, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 20, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 13, 2017 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
Other documents for Sun Pharmaceutical Industries, Inc.
- FDA Inspection 1256351 - 2025-04-18
- FDA Inspection 1113608 - 2019-12-23
- FDA Inspection 1047959 - 2018-03-19
- FDA Inspection 1037539 - 2017-12-20
- FDA Inspection 1031333 - 2017-11-13
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