Company
IndiaIntas Pharmaceuticals Limited, Ahmedabad, India – FDA Inspections
Inspection records and compliance data for Intas Pharmaceuticals Limited in Ahmedabad. 8 FDA inspections on record (1 OAI), 3 Form 483s, 2 warning letters, last inspected December 02, 2022.
Company Profile
This profile covers Intas Pharmaceuticals Limited based in Ahmedabad, India.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 4
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 2
First inspected October 21, 2011. Last inspected December 2, 2022.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Procedures not in writing, fully followed2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 2, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1191818 |
| February 28, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1119170 |
| May 28, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1092798 |
| June 19, 2017 | Not classified | Human Drugs · Generic Drug Evaluation | 1014641 |
| October 19, 2016 | VAI | Human Drugs · Drug Quality Assurance | 992746 |
| December 19, 2014 | NAI | Human Drugs · Drug Quality Assurance | 910188 |
| June 27, 2013 | NAI | Human Drugs · Drug Quality Assurance | 847008 |
| October 21, 2011 | VAI | Human Drugs · Drug Quality Assurance | 755472 |
FDA documents
Form 483s (3)
- Form 483s · December 2, 2022
- Form 483s · February 28, 2020
- Form 483s · May 28, 2019
Warning Letters (2)
Other regulators (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Intas Pharmaceuticals Limited
FEI Number
3004011473
Address
Plot No. 5 To 14, Pharmez, Near Village Matoda, Sarkhej-Bavla National Highway No. 8-A, Taluka, Sanand, Ahmedabad, India
Country
India
ID: cfedbb2f-5587-42dc-985b-044083dd01e5