Company
IndiaApotex Pharmachem India Pvt Ltd., Bangalore, India – FDA Inspections
Inspection records and compliance data for Apotex Pharmachem India Pvt Ltd. in Bangalore. 7 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected March 14, 2025.
Company Profile
This profile covers Apotex Pharmachem India Pvt Ltd. based in Bangalore, India.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected December 1, 2010. Last inspected March 14, 2025.
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 14, 2025 | Not classified | Human Drugs | 1263710 |
| September 2, 2022 | NAI | Human Drugs · Bioresearch Monitoring | 1180313 |
| January 31, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1118806 |
| June 26, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1057873 |
| June 3, 2016 | VAI | Human Drugs · Drug Quality Assurance | 978926 |
| January 31, 2014 | OAI | Human Drugs · Drug Quality Assurance | 868946 |
| December 1, 2010 | VAI | Human Drugs · Drug Quality Assurance | 711567 |
FDA documents
Form 483s (1)
Warning Letters (1)
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Company Information
Name
Apotex Pharmachem India Pvt Ltd.
FEI Number
3005466325
Address
Plot 1a Bommasandra Industrial Area 4th Phase, Jigani Link Road, Bommasandra Ind. Estate, Bangalore, India
Country
India
ID: 8aa6fc29-dc9f-4154-90af-d0bf193414c5