FDA Inspection
Sun Pharmaceutical Industries Ltd.Sun Pharmaceutical Industries Ltd. – FDA Inspection, Aug 31, 2018
Record Details
This FDA Inspection record concerns Sun Pharmaceutical Industries Ltd., with an inspection on August 31, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Angela E. Glenn (Issuing Officer)
- Sarah Ibrahim (Issuing Officer)
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ID · c8fba698-5059-439e-82a2-4dfe1ac4efc6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064495
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)(1)Sample size - test intervals
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Sun Pharmaceutical Industries Ltd.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
| May 9, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 11, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 6, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sun Pharmaceutical Industries Ltd.
- FDA Inspection 1272871 - 2025-06-13
- FDA Inspection 1169254 - 2022-05-09
- FDA Inspection 1112832 - 2019-12-13
- FDA Inspection 1095656 - 2019-06-11
- FDA Inspection 1076538 - 2018-12-06
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