Company
IndiaSolara Active Pharma Sciences Limited, Chennai, India – FDA Inspections
Inspection records and compliance data for Solara Active Pharma Sciences Limited in Chennai. 4 FDA inspections on record, last inspected August 09, 2024.
Company Profile
This profile covers Solara Active Pharma Sciences Limited based in Chennai, India.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 14, 2012. Last inspected August 9, 2024.
Most cited issue areas
- Drug products - samples representative, identified properly1 inspection
- Lack of quality control unit1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 9, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1245977 |
| December 14, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1077338 |
| August 31, 2016 | VAI | Human Drugs · Drug Quality Assurance | 983873 |
| December 14, 2012 | VAI | Human Drugs · Drug Quality Assurance | 813770 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Solara Active Pharma Sciences Limited
FEI Number
3002808131
Address
Keelakottaiyur Village, Melakottaiyur (Post), 27 Vandaloor Kelambakkam Road, Chennai, India
Country
India
ID: 93779293-d0c0-467d-b998-19f5ba471173