FDA Inspection
Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. – FDA Inspection, Apr 25, 2012
Record Details
This FDA Inspection record concerns Sun Pharmaceutical Industries, Inc., with an inspection on April 25, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 25, 2012
- Product Type
- Drugs
View Company Profile
ID · bd91b987-220b-46df-b5b9-02a174305244
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779821
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.111Establishment of time limitations
Full citation text and observation details available on the Dashboard.
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 |
| November 13, 2017 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
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 1031333 - 2017-11-13
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.