FDA Inspection
SUN PHARMACEUTICAL INDUSTRIES INCSUN PHARMACEUTICAL INDUSTRIES INC – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns SUN PHARMACEUTICAL INDUSTRIES INC, with an inspection on March 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 737d2fc2-2394-43e2-b8ee-93af3205b52c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043676
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.130(e)Packaging line inspection after use
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SUN PHARMACEUTICAL INDUSTRIES INC
13| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2026 | Not classified | New Jersey District Office | Bioresearch Monitoring |
| December 12, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 10, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 8, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 18, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SUN PHARMACEUTICAL INDUSTRIES INC
- FDA Inspection 1328400 - 2026-07-24
- FDA Inspection 1230974 - 2024-12-12
- FDA Inspection 1179668 - 2022-08-10
- FDA Inspection 1083409 - 2019-03-08
- FDA Inspection 1068971 - 2018-09-18
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