Company
IndiaAlembic Pharmaceuticals Limited, Vadodara, India – FDA Inspections
Inspection records and compliance data for Alembic Pharmaceuticals Limited in Vadodara. 5 FDA inspections on record, 2 Form 483s, last inspected March 10, 2023.
Company Profile
This profile covers Alembic Pharmaceuticals Limited based in Vadodara, India.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 19, 2018. Last inspected March 10, 2023.
Most cited issue areas
- In-process conformity - examination, sample testing1 inspection
- Scientifically sound laboratory controls1 inspection
- Test devices not meeting specifications1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 10, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1203306 |
| January 8, 2020 | NAI | Human Drugs · Bioresearch Monitoring | 1118669 |
| September 20, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1102336 |
| February 8, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1078542 |
| October 19, 2018 | Not classified | Human Drugs | 1074508 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Alembic Pharmaceuticals Limited
FEI Number
3013826490
Address
Derma Division, Plot No 779/P & 790/P, Village Karakhadi, Taluka Padra, Vadodara, India
Country
India
ID: 378b93aa-98ff-4894-93aa-5e799d703e62