FDA Inspection
Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. – FDA Inspection, Nov 13, 2017
Record Details
This FDA Inspection record concerns Sun Pharmaceutical Industries, Inc., with an inspection on November 13, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a593214f-ca39-495e-b33c-7560210ec480
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031333
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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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 |
| June 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 981368 - 2016-06-29
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