Company
IndiaGalentic Pharma (India) Private Limited, Navi Mumbai, India – FDA Inspections
Inspection records and compliance data for Galentic Pharma (India) Private Limited in Navi Mumbai. 2 FDA inspections on record (1 OAI), 2 Form 483s, last inspected February 12, 2018.
Company Profile
This profile covers Galentic Pharma (India) Private Limited based in Navi Mumbai, India.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected March 3, 2017. Last inspected February 12, 2018.
Most cited issue areas
- Buildings not maintained in good state of repair1 inspection
- Cleaning System1 inspection
- Computer control of master formula records1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 12, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1044234 |
| March 3, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1006302 |
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
Galentic Pharma (India) Private Limited
FEI Number
3008523281
Address
Unit 1, R-673 T T C Midc, Thane Belapur Road, Navi Mumbai, India
Country
India
ID: eeeade0d-a5a2-4643-bfb4-4de6468e0d9c