FDA Inspection
Sun Pharmaceuticals Industries Ltd.Sun Pharmaceuticals Industries Ltd. – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns Sun Pharmaceuticals Industries Ltd., with an inspection on March 29, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Angela E. Glenn (Issuing Officer)
- Cheryl A. Clausen
View Company Profile
ID · 717d799f-5a57-4d12-a329-0ca55d8d7813
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084595
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.84(c)(4)Composite sample top/middle/bottom
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.80(a)Procedures To Be in Writing
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sun Pharmaceuticals Industries Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2023 | Not classified | Office of Inspections and Investigations | |
| April 13, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sun Pharmaceuticals Industries Ltd.
- FDA Inspection 1225726 - 2023-12-15
- FDA Inspection 1012008 - 2017-04-13
- FDA Inspection 915847 - 2015-01-30
- FDA Inspection 834084 - 2013-05-10
- FDA Inspection 738976 - 2011-06-17
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.