Company
IndiaAlkem Laboratories Limited, India – FDA Inspections
Inspection records and compliance data for Alkem Laboratories Limited. 1 FDA inspection on record, 1 Form 483, last inspected July 03, 2026.
Company Profile
This profile covers Alkem Laboratories Limited based in India.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected July 3, 2026.
Most cited issue areas
- Equipment Design, Size and Location1 inspection
- Written procedures not established/followed1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 3, 2026 | Not classified | Human Drugs · Generic Drug Evaluation | 1325062 |
FDA documents
Form 483s (2)
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Company Information
Name
Alkem Laboratories Limited
FEI Number
3016480976
Address
India
Country
India
ID: 278691dd-5d9a-4c1d-ba5e-72166fce32d1