Company
IndiaApicore Pharmaceuticals Private Ltd, Vadodara, India – FDA Inspections
Inspection records and compliance data for Apicore Pharmaceuticals Private Ltd in Vadodara. 6 FDA inspections on record, 2 Form 483s, last inspected May 05, 2023.
Company Profile
This profile covers Apicore Pharmaceuticals Private Ltd based in Vadodara, India.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 12, 2011. Last inspected May 5, 2023.
Most cited issue areas
- Calibration/Inspection/Checking not done1 inspection
- Validation lacking for sterile drug products1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 5, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1206636 |
| November 8, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1113142 |
| January 25, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1040683 |
| March 25, 2016 | VAI | Human Drugs · Drug Quality Assurance | 965189 |
| June 13, 2014 | VAI | Human Drugs · Drug Quality Assurance | 885835 |
| September 12, 2011 | VAI | Human Drugs · Drug Quality Assurance | 745467 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Apicore Pharmaceuticals Private Ltd
FEI Number
3006767695
Address
Block No 252-253, Village-Dhobikuva, Opposite Jain Irrigation, Vadodara, India
Country
India
ID: c91652e8-564d-4fbc-aff9-9f6ebd395cc4