Company
IndiaAlkem Laboratories Limited, Ankleshwar, India – FDA Inspections
Inspection records and compliance data for Alkem Laboratories Limited in Ankleshwar. 3 FDA inspections on record, 1 Form 483, last inspected April 07, 2023.
Company Profile
This profile covers Alkem Laboratories Limited based in Ankleshwar, India.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 23, 2013. Last inspected April 7, 2023.
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 7, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1206190 |
| December 9, 2016 | VAI | Human Drugs · Drug Quality Assurance | 998189 |
| November 23, 2013 | VAI | Human Drugs · Drug Quality Assurance | 856244 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
- EMA · 1 inspection · last December 22, 2011
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Company Information
Name
Alkem Laboratories Limited
FEI Number
3006851796
Address
Plot No 288, A 289 & 290 G I D C; Gidc Naka, Ankleshwar, India
Country
India
ID: 21ededd9-bda7-4b49-a6c8-b85749a9d7a8