Company
IndiaFresenius Kabi Oncology Limited, Baddi, India – FDA Inspections
Inspection records and compliance data for Fresenius Kabi Oncology Limited in Baddi. 6 FDA inspections on record (3 OAI), 2 Form 483s, last inspected October 10, 2023.
Company Profile
This profile covers Fresenius Kabi Oncology Limited based in Baddi, India.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 3
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected November 20, 2008. Last inspected October 10, 2023.
Most cited issue areas
- Procedures for sterile drug products3 inspections
- Scientifically sound laboratory controls3 inspections
- Cleaning / Sanitizing / Maintenance2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 10, 2023 | OAI | Human Drugs · Drug Quality Assurance | 1220476 |
| April 14, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1010068 |
| May 22, 2015 | OAI | Human Drugs · Drug Quality Assurance | 927828 |
| August 28, 2012 | VAI | Human Drugs · Drug Quality Assurance | 800493 |
| November 20, 2009 | VAI | Human Drugs · Drug Quality Assurance | 636945 |
| November 20, 2008 | VAI | Human Drugs · Drug Quality Assurance | 554278 |
FDA documents
Form 483s (1)
Other regulators (1)
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Company Information
Name
Fresenius Kabi Oncology Limited
FEI Number
3006210232
Address
Tehsil Nalagarh, Nalagarh Baddi Road, Baddi, India
Country
India
ID: d092c98c-aa35-490f-97c4-3ed02fe7dac7