Company
IndiaSoftgel Healthcare Private Limited, Kancheepuram District, India – FDA Inspections
Inspection records and compliance data for Softgel Healthcare Private Limited in Kancheepuram District. 4 FDA inspections on record, 2 Form 483s, last inspected February 14, 2025.
Company Profile
This profile covers Softgel Healthcare Private Limited based in Kancheepuram District, India.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected June 29, 2012. Last inspected February 14, 2025.
Most cited issue areas
- Computer control of master formula records2 inspections
- Procedures not in writing, fully followed2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1262422 |
| February 22, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1080044 |
| April 29, 2016 | VAI | Human Drugs · Drug Quality Assurance | 970787 |
| June 29, 2012 | VAI | Human Drugs · Drug Quality Assurance | 789360 |
FDA documents
Other regulators (2)
- EMA · 1 inspection · last July 6, 2012
- UK MHRA · 1 inspection · last March 23, 2009
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Company Information
Name
Softgel Healthcare Private Limited
FEI Number
3006381009
Address
Survey No. 20/1, Vandalur-Kelambakkam Rd, Kancheepuram District, India
Country
India
ID: 60e6960a-1e97-496a-8a60-afb3e124b1aa