Company
IndiaAmoli Organics (A Division of Umedica Laboratories Pvt Ltd), Vapi, India – FDA Inspections
Inspection records and compliance data for Amoli Organics (A Division of Umedica Laboratories Pvt Ltd) in Vapi. 6 FDA inspections on record, 1 Form 483, last inspected March 04, 2024.
Company Profile
This profile covers Amoli Organics (A Division of Umedica Laboratories Pvt Ltd) based in Vapi, India.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 30, 2010. Last inspected March 4, 2024.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- Storage under appropriate conditions1 inspection
- Written sanitation procedures not followed1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 4, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1231931 |
| July 20, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1065141 |
| March 31, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1018720 |
| February 12, 2016 | VAI | Human Drugs · Drug Quality Assurance | 957768 |
| April 24, 2014 | VAI | Human Drugs · Drug Quality Assurance | 878346 |
| September 30, 2010 | VAI | Human Drugs · Drug Quality Assurance | 684841 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Optimus Drugs Private Limited
Covalent Laboratories Pvt Ltd
Srini Pharmaceuticals Private Limited
Sun Pharmaceutical Industries Ltd.
Divi's Laboratories Limited, Unit-1
Rampex Labs Pvt., Ltd.
Maithri Laboratories Private Limited
Maithri Drugs Private Limited
Unichem Laboratories Limited
Laxai Life Sciences Private Limited
Company Information
Name
Amoli Organics (A Division of Umedica Laboratories Pvt Ltd)
FEI Number
3004810446
Address
Plot No 322/4, 40 Shed Area; Gidc, Vapi, India
Country
India
ID: a4e60370-5adf-4abb-b455-03bb222208b8