FDA Inspection
Sun Pharmaceutical Industries, LTD.Sun Pharmaceutical Industries, LTD. – FDA Inspection, Dec 14, 2011
Record Details
This FDA Inspection record concerns Sun Pharmaceutical Industries, LTD., with an inspection on December 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 14, 2011
- Product Type
- Drugs
View Company Profile
ID · 0c401807-fb22-407a-9743-374c303e2b95
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 759172
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192No written record of investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sun Pharmaceutical Industries, LTD.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 30, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 11, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 26, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Sun Pharmaceutical Industries, LTD.
- FDA Inspection 862802 - 2014-01-21
- FDA Inspection 833497 - 2013-05-30
- FDA Inspection 815058 - 2013-01-11
- FDA Inspection 792974 - 2012-08-03
- FDA Inspection 746953 - 2011-09-26
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.