Company
IndiaRubicon Research Private Limited, Ambarnath, India – FDA Inspections
Inspection records and compliance data for Rubicon Research Private Limited in Ambarnath. 7 FDA inspections on record, 2 Form 483s, last inspected November 07, 2024.
Company Profile
This profile covers Rubicon Research Private Limited based in Ambarnath, India.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected April 11, 2013. Last inspected November 7, 2024.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Cleaning / Sanitizing / Maintenance1 inspection
- In-process materials characteristics testing1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1250746 |
| March 8, 2024 | NAI | Human Drugs · New Drug Evaluation | 1231826 |
| January 27, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1195651 |
| August 30, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1102226 |
| November 20, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1038536 |
| March 13, 2015 | NAI | Human Drugs · Drug Quality Assurance | 924394 |
| April 11, 2013 | VAI | Human Drugs · Drug Quality Assurance | 828916 |
FDA documents
Form 483s (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Rubicon Research Private Limited
FEI Number
3008252295
Address
4 & K30 5 Plot No K - 30, Ambarnath, India
Country
India
ID: 07d24fe7-deaa-4c5a-9fd3-9562d3cefd6f