Company
IndiaAlkem Laboratories Limited, Baddi, India – FDA Inspections
Inspection records and compliance data for Alkem Laboratories Limited in Baddi. 12 FDA inspections on record, 3 Form 483s, last inspected March 27, 2024.
Company Profile
This profile covers Alkem Laboratories Limited based in Baddi, India.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 7
- NAI
- 2
- Unclassified
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected November 6, 2009. Last inspected March 27, 2024.
Most cited issue areas
- Acceptance of in-process materials1 inspection
- Approve or reject components, products1 inspection
- Procedure Deviations Recorded and Justified1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 27, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1233569 |
| February 21, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1118336 |
| November 26, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1140381 |
| August 23, 2019 | Not classified | Human Drugs | 1105480 |
| May 17, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1089865 |
| August 10, 2018 | Not classified | Human Drugs | 1072545 |
| September 15, 2017 | Not classified | Human Drugs | 1025979 |
| March 10, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1007598 |
| July 31, 2015 | VAI | Human Drugs · Drug Quality Assurance | 939486 |
| September 20, 2013 | NAI | Human Drugs · Drug Quality Assurance | 853251 |
| August 31, 2012 | NAI | Human Drugs · Drug Quality Assurance | 802325 |
| November 6, 2009 | VAI | Human Drugs · Drug Quality Assurance | 634479 |
FDA documents
People (5)
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Company Information
Name
Alkem Laboratories Limited
FEI Number
3006370533
Address
1553 1558 1559 Tehsil Nalagarh, Khasra No 1544; Village Thana, Baddi, India
Country
India
ID: 308e3070-8ca9-4084-a117-315b7e3f8ba8