Company
IndiaSoftech Pharma Pvt. Ltd., Dabhel, India – FDA Inspections
Inspection records and compliance data for Softech Pharma Pvt. Ltd. in Dabhel. 4 FDA inspections on record, 1 Form 483, last inspected March 07, 2025.
Company Profile
This profile covers Softech Pharma Pvt. Ltd. based in Dabhel, India.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 11, 2015. Last inspected March 7, 2025.
Most cited issue areas
- Computer control of master formula records1 inspection
- Investigations made into any unexplained discrepancy1 inspection
- Training , Education , Experience overall1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 7, 2025 | Not classified | Human Drugs | 1266353 |
| December 13, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1115367 |
| February 10, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1002973 |
| December 11, 2015 | VAI | Human Drugs · Drug Quality Assurance | 954258 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Softech Pharma Pvt. Ltd.
FEI Number
3007721548
Address
Behind Somnath Temple, 708/6 Somnath Road, Dabhel, India
Country
India
ID: 22b2c113-bdc3-46f2-945b-3031893f0e1c