Company
IndiaAlkem Laboratories Limited, Daman, India – FDA Inspections
Inspection records and compliance data for Alkem Laboratories Limited in Daman. 7 FDA inspections on record, 3 Form 483s, last inspected May 01, 2026.
Company Profile
This profile covers Alkem Laboratories Limited based in Daman, India.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected December 9, 2011. Last inspected May 1, 2026.
Most cited issue areas
- Approve or reject components, products1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Complete test data included in records1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 1, 2026 | Not classified | Human Drugs | 1313924 |
| August 30, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1106347 |
| January 18, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1080442 |
| March 27, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1046054 |
| September 29, 2016 | VAI | Human Drugs · Drug Quality Assurance | 989408 |
| October 25, 2013 | VAI | Human Drugs · Drug Quality Assurance | 854604 |
| December 9, 2011 | VAI | Human Drugs · Drug Quality Assurance | 761720 |
FDA documents
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Alkem Laboratories Limited
FEI Number
3006370524
Address
165 1 165 2 165 3 168 215 168 216 168 234 Plot No 164, Srv No 167; Village Dabhel, Daman, India
Country
India
ID: 7c321501-cc0f-4d6e-9f1c-7249e0e0595a